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Intrapartum Social Support and Exclusive Breastfeeding in Mexico

Ana Langer The Population Council, Regional Office for Latin America and the Caribbean

Lourdes Campero Cecilia Garcia

Center for Research on Population Health, National Institute of Public Health, Mexico

Sofia Reynoso Department of Reproductive Health, Ministry of Health, Mexico

September 1996

This activity was supported by the United States Agency for International Development (USAJD) under Cooperative Agreement No. DPE-5966-A-00-1045-00. The contents of this document do not necessarily reflect the views or policies ofUSAJD.

WELLSTART INTERNATIONAL

Expanded Promotion of Breastfeeding Program

3333 K Street, NW, Suite 101

Washington, DC 20007

USA

Tel (202)298-7979 • Fax (202)298-7988

B

Research Monograph iii

Table of Contents

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Project Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Conceptual Bases and Hypotheses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Study Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Description of the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Recruitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 The Intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Training the Doulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Evaluation of the Intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Effects on the Health of the Mother and the Newborn and on Breastfeeding . . . . . . . . . . 9 Cost-effectiveness ........................................................ 10 Perception and Experiences of the Women, the Dou/as, and the Hospital Staff . . . . . . . 11

Results ............................................................................... 13 Effects on the Health of the Mother and the Newborn and on Breastfeeding . . . . . . . . . . . . . 13 Cost-Effectiveness .............................................................. 16 Perception and Experiences of the Women, the Doulas, and the Hospital Staff ........... 17

Discussion and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Figures and Tables .................................................................... 23

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Research Monograph v

Acknowledgements

This research was made possible thanks to the support of various organizations and individuals such as:

Wellstart International which provided the necessary funds for the project as well as technical advice. The authorities of the Mexican Social Security Institute who gave us permission to undertake the research project in one of their hospitals. Dr. Rene Bailon, Director General of the Luis Castelazo Ayala Hospital, who gave us the opportunity to start the trial. Dr. Loera, Head of the Obstetrics Service (morning shift) and Dr. Hernandez Cabrera (afternoon shift), who provided facilities for us to work in their services. Miss Elvira Cuevas, Head Nurse, was ever helpful to the people who did the field work in the hospital. The medical and nursing staff, to whom we express our thanks for their availability and the help given during the field work, especially the Obstetrics Service personnel. Dr. Gilberto Tena, who gave us his support at the beginning of the project and offered us the first opportunity to discuss it in an academic forum.

We are also indebted to the National Institute of Public Health (INSP) authorities, particularly Dr. Mauricio Hernandez, for their great interest, support and advice in making the project a success. We are grateful to Dr. Juan Rivera for including the project in his Department's program of work. We thank Dr. Teresita Gonzalez de Cossio and Mrs. Maire Vallejo for their participation in the methodological design of the project and their suggestions as to how to prepare some of the information collection mechanisms. Special mention must be made of the Doulas: Amada Barraza, Margarita Catafio, Ma. Antonieta Caballero, Ma. Ines Gamez, Lilia Jimenez, Guadalupe Mendoza, Sandra Melendez, Patricia Martinez and Guadalupe Vargas, for their great devotion to the daily work needed to attain the project's objectives. We also wish to thank Gloria Guadarrama and Aurora Medina who, besides being Doulas, were responsible for the important task of promoting breastfeeding.

The assistance of the team at the Childbirth Education Center (CEPAPAR) was invaluable in organizing and giving the training course forthe doulas. We particularly wish to express our thanks to Dr. Tere Ludlow and to the instructor Mireille Stoppen whose constant advice and supervision when we began the field work were of great help.

We are indebted too to Dr. Marshall Klaus and Dr. John Kennel who were most enthusiastic that this project be developed in Mexico. Our thanks are due also to Dr. Penny Simkin for her advice during the initial stage of our work, as well as to several members ofDoulas of North America (DONA), especially Nadia andAshela, who showed great interest in training a group of Mexican doulas.

We wish to mention the project's evaluation team's social workers and psychologists, Vanessa Flores, Victoria Cervantes, Inna Aldana and Guadalupe Perez, who contributed to the project by registering data from hospital records, interviewing women in the hospital and at home, as well as coding and sorting the information obtained.

Lie. Martha Loya, who did some of the qualitative study interviews, and Lie. Olivia Ortiz and Mtra. Carmen Diaz, who were responsible for the qualitative study interviews as well as sorting and analyzing the information, were enthusiastic participants. We also express our appreciation to Dr. Roberto Castro for his advice in designing the qualitative study for the project.

Thanks are due also to Dr. Leticia Avila for her participation in the cost-effectiveness study, together with Dr. Raul Garcia Barrios, who developed a mathematical model to analyze the variables in this part of the study.

j)

vi Wellstart Jnternational's Expanded Promotion ofBreastfeeding (EPB) Program

We wish to make special mention of the assistance provided by Ing. Anbtonio Garcia and his work team, especially Mimi, Maire and Rocio, who helped us to prepare the computer programs to register the information. We are grateful too to Nora Aldama, who was in charge of an important part of the work of entering the date in the computer. Our appreciation to Lie. Juan Eugenio Hernandez for his advice and help in the statistical analysis of the information and to Rosy de Hernandez for her programming work and assistance in the statistical analysis of information.

We owe a debt of gratitude to The Population Council for its great support throughout the project. We particularly wish to thank Dr. Kathryn Tolbert, Tere Ulloa, Silvia Llaguno and Irma Ballesteros in the Regional Office, and Carol Hendrick in New York.

We appreciate the support given by the Mexico Health Foundation in its efficient handling of the project's finances. Special thanks go to Mr. Francisco Morales and Mrs. Maria de la Luz Ruiz Sanchez, who supervised it.

We are grateful to Lie. Jesus Pulido of the INSP for his constant assistance in solving logistical and financial questions involving the project Our thanks also to Blanca Gomez, Martha L6pez and Laura Diaz for their great help and efficient secretarial work through this study.

But, above all, we express our very special thanks to all the women who took part in the project for their confidence and willingness to cooperate in this type of study.

Research Monograph vii

Executive Summary

In Mexico, care provided to women chning pregnancy, childbirth, and the period following childbirth has become increasingly medicalized during the last decade. In effect, care is provided exclusively by the doctor and nurse, both of whom consider that labor and childbirth may well result in a pathological condition in which the mother and/or child requires specializ.ed and technological attention if it is to be successfully cured. This care model has lllldoubteclly contributed to the reduction in the death rate for women in Mexico in recent decades, and to fewer perinatal diseases and deaths. However, it has deprived the women of the support they traditionally received from the midwife, their families, and women in the community, and it has dehumanized the childbirth experience to the point that it has become a mechanical and intimidating process.

In short, the pregnant woman is alone, in an unknown and frightening situation and being attended to by overworked hospital staff who, consequently, have little patience with and are not receptive to her needs. The fear, anxiety, and pain resulting from this situation contribute to increased medical interventions.

Study Objective

The purpose of the project was to design, implement, and evaluate an intervention consisting of psychosocial support during labor, childbirth, and the immediate postpartum period to improve the health of the mother and the child and increase the duration of exclusive breastfeeding. The intervention consisted of giving a woman who is having her first baby the continuous physical and emotional support of another woman who is exclusively dedicated to this task (a "doula") during labor and childbirth. This type of assistance was meant to improve the conditions in which labor takes place; to make mothers feel better and increase their participation in the birth and, consequently, to reduce the need for medical intervention during childbirth. Furthermore, it was hoped to promote mother-child bonding and make breastfeeding easier.

Intervention

The intervention was evaluated by means of a randomized clinical trial, an ethnographic qualitative study, and a study of the program's cost-effectiveness. The last mentioned is considered to be an essential element in proposing recommendations about the decisions that health authorities should make. Studies in Guatemala, the United States, and South Africa on the participation of doulas have shown positive effects: a reduction of the use of anesthesia and analgesics during labor, in the number of cesarean sections, the use of forceps, and in the length oflabor. Similarly, the studies demonstrated that companion support during labor speeded up the mother's recovery, helped mother-child bonding, and reduced anxiety and depression in the first six weeks postpartum. It was also found that psychosocial support during labor had a positive effect on the start and continuation of breastfeeding. The effect on exclusive breastfeeding, however, was unknown.

The evaluation of the program was threefold: the effects on the health of the mother and child were measured by means of a randomized clinical trial; cost-effectiveness was measured by a health economics study; and, finally, women's perceptions and satisfaction were assessed by a qualitative study, as well as the health services personnel's viewpoints about the program.

The program consisted of continuous support provided by the doula to the mother during labor and delivery, with the following components: emotional support, information, physical support, communication, and immediate

viii Wellstart Intemational's Expanded Promotion of Breastfeeding (EPB) Program

contact between mother and child. The experiment continued in the period immediately after birth when the doula visited the mother in the maternity ward. During this visit, the doula told the mother about the benefits of exclusive breastfeeding and how to solve breastfeeding problems she might encounter.

The evaluation was to measure the effects of the intervention on medical activities and procedures during labor and childbirth, the health of the mother and of the newborn, the emotional state of the mother, breastfeeding, and the health of the baby and prevalence of exclusive breastfeeding a month after birth. The evaluation was made through home visits community breastfeeding promoters blinded to the treatment group to which the mother had been assigned.

Sample

A total of 724 women were recruited, 363 (50.1%) forthe control group and 361 (49.9%) for the intervention group. There was an attrition rate of 9 .5%, with no significant differences between the intervention and control groups. The randomization process was efficient and it produced two homogenous groups as to their socio-economic level, reproductive history, and emotional state upon entry.

Effect on Labor and Delivery

In comparing incidence of cesarean ection, epidural anesthesia, and use of forceps in the control and intervention groups, no statistically significant differences were found, although a tendency was confirmed towards more medical and surgical interventions in the control group. These results show that, unlike previous studies, the intervention did not change rigid institutional practices that have little relation to the peculiarities of the women and their labor. A clear significant statistical difference appears in the length of labor (3. 83 hours in the intervention group and 4.8 hours in the control group).

There were no differences between intervention and control groups regarding neonatal conditions or maternal reports of pain or anxiety. However, in relation to women's emotional conditions, those in the intervention group had a much greater control over their experience than their counterparts in the control group.

Effect on Infant Feeding Patterns

Only 9°/o of the total sample began breastfeeding in the hours immediately following birth and the intervention did not alter institutional norms that delay initiation of breastfeeding. However, the prevalence of exclusive breastfeeding at one month was significantly higher in the intervention group (12% versus 7%). Feeding on demand was most common in both groups. All behavior recommended to promote breastfeeding (care of the nipples, hygiene, etc.) was significantly better in the intervention group and illustrates the positive effect of the talk on breastfeeding given in the hospital by the doula.

Reasons for supplementation and/or weaning included problems with nipples, return to work, maternal or infant sickness, perception by the mother that "there was not enough milk" or "the baby did not like it," a recommendation by some family member or by the doctor, etc. There were significant differences in favor of the intervention group in respect of "the doctor's advice," "the milk dried up," and "the mother was hospitalized." These differences seem to imply that the women in the control group supplemented their milk with formula

Research Monograph ix

because of reasons based on popular beliefs about breastfeeding, or because they had been given recommendations by doctors who, unfortunately, too often and with little foundation, recommended a supplement. The women in the intervention group appear to have been better prepared to ignore this advice; they only added a supplement when health problems arose. The cost-effectiveness analysis showed that, despite the limited overall effect of the intervention, it was still cost-effective as compared to routine care.

Programmatic Implications

The characteristics of the hospital and of the women admitted to it are those which best explain the limited effects of our study on medical interventions. However, positive effects on the emotional state of the mothers, length of labor, and duration of exclusive breastfeeding were found. Use of doulas is cost-effective and can be recommended to those responsible for clinical services. To increase their cost-effectiveness, consideration should be given to applying the program in hospital units with less inclination towards medical interventions.

Research Monograph 1

Introduction

In Mexico, as in most countries, care to be provided to women during pregnancy, childbirth and the period following childbirth has become increasingly medicalized during the last decade. There are different reasons for this: on the one hand, the intense and rapid urbanization in Mexico means that more than 60% of women live in cities and, as a consequence, have access to many public and private obstetrics services and public health institutions. On the other hand, most people, especially those living in urban areas, believe that the Western medical model is the best; midwives are looked down on as old-fashioned and only being good enough for peasants and the uneducated.

Health professionals (doctors and nurses), for their part, are unaware of the important traditional role played by others during childbirth, such as women who are family or community members, and traditional birth attendants. Furthermore, in Mexico only some private hospitals allow a woman's partner to be present, and there is no training program for midwives.

All of the above is reflected in national statistics that show that 85.4% of births take place in hospitals, 3.3% at the home of a traditional midwife, and 10% at the pregnant woman's home (SSA, 1994). The proportion of hospital births was substantially higher in 1994 than in 1987 (SSA, 1987). The 1994 study shows that in the Mexico City metropolitan area medical attention is given in 98% of deliveries (SSA, 1994).

What type of care do Mexican hospitals provide during pregnancy, childbirth and the postpartum period?1 In general, and as mentioned above, the model may be defined as being "medical-institutional." In effect, care is provided exclusively by the doctor and nurse, both of whom consider that labor and childbirth may well result in a pathological condition in the mother and/or the child, requiring specialized and technological attention if it is to be success:fully cured. Most births take place in units with inpatient and anesthesia facilities, and within an operating theater. The prevailing tendency is to induce and/or direct labor and to give the women epidural anesthesia; about 20% of births are by cesarean section, with variations depending on the institutions. There are no trained midwives and public hospitals do not permit the partner or any family member to enter the maternity ward. This care model has undoubtedly contributed to the reduction in the death rate for women in Mexico in recent decades (Langer et al., 1994), and to fewer perinatal diseases and deaths. However, it has deprived the women of the support they traditionally received from the midwife, their families, and women of the community, and it has dehumanized the childbirth experience to the point that it has become a mechanical and intimidating process.

What happens when a woman in labor arrives at the hospital? After waiting for some time, she is checked by an Emergency Room physician who, depending on the condition of the uterus and the cervix, decides whether she should be admitted. If the decision is positive, she takes leave of her family members and is "prepared" for childbirth: she is placed on a gurney, given intravenous fluids, is not offered any food and her movements are limited; she is given a trichotomy and an enema and is taken to the maternity ward where there are usually other women in a similar condition. In the maternity ward each woman is occasionally checked by a physician and a nurse whom the woman has never seen before and who will probably be replaced by others if labor lasts beyond their shift; in the intervals between the doctor's and nurses' visits, the woman is left alone. She is often "scolded"

'In Mexico, 17.4% of births take place in institutions of the Ministry of Health (open to the public in general and practically free); 32.1 % in the Mexican Social Security Institute (IMSS) which covers private sector workers; and 22.1 % receive private medical attention (SSA, 1994).

2 Wellstart International's Expanded Promotion ofBreastfeeding (EPB) Program

if she "loses control", and the most common method of calming her is to use an epidural block. If labor is prolonged, it is common practice to interrupt it by performing a cesarean section. In short, the pregnant woman is alone, in an unknown and frightening situation (labor itself, especially if it is her first time, the surroundings she finds herself in, and the treatment to which she is subjected), being attended to by overworked hospital staff who, consequently, have little patience with and are not receptive to the needs of the woman in labor.

These circumstances have a negative effect on her emotional state and make one of her most important and significant life experiences a painful and traumatic process. But the implications do not end there. Fear, anxiety and pain contribute to increase medical interventions. Labor that began normally is speeded up by the application of an oxytocic; now the frequency and intensity of the contractions cause the mother pain and distress which, together with the lack of information and of a supportive companion, induce her to lose control, to complain, and to become uncooperative with the hospital staff.

At the first sign that the pregnant woman might demand a lot of time or attention on the part of the hospital staff, it is decided to apply an epidural block which, while it eases the pain, makes labor last longer. By making her less sensitive the mother is not as cooperative as she might be in the active stages of childbirth, such as that immediately preceding expulsion.

These circumstances lead to the process being interrupted either by a cesarean section or by the use of forceps, with the consequences that are well known for the health of the mother and the newborn baby; and the need to use more institutional resources such as health personnel, facilities, medicines, etc. A child and/or mother recovering after a difficult birth take longer to bond and there is considerably less chance of the mother being able to successfully breastfeed the baby. These are the conditions in which a large proportion of women in Mexico give birth.

The conviction that the birth of a child is a physiological occurrence, that in more than 90% of cases it requires neither special medical intervention nor the use of advanced technology, and that it is one of the most important experiences for the majority of women, together with Mexico's real shortage of health care resources, that should be spent on more urgent problems, led us to propose the provision of the type of support which is the subject of this study.

The purpose of the project was to design, implement, and evaluate an intervention consisting of psychosocial support during labor, childbirth, and the immediate postpartum period in order to improve the health of the mother and the child, as well as to increase breastfeeding. This intervention consists of giving a woman who is having her first baby the continuous physical and emotional support of another woman who is exclusively dedicated to this task (a "Doula"2

) during labor and childbirth (Klaus, et al., 1993).

This type of assistance was meant to improve the conditions in which labor takes place: to make mothers feel better and increase their participation and, consequently, to reduce the need for medical intervention during childbirth. Furthermore, it was hoped to promote mother-child bonding and make breastfeeding easier.

The intervention was evaluated by means of a randomized clinical trial, an ethnographic qualitative study and a study of the program's cost-effectiveness. The last mentioned is considered to be an essential element in

2 "Doula" is a Greek word refening to an experienced woman who helps other women. The word has now come to mean a woman experienced in childbirth who provides continuous physical, emotional, and information support to the mother before, during and just after childbirth (Klaus, et al., 1993).


proposing recommendations about the decisions that health authorities should make. The protocol was reviewed and approved by the research and ethics committees of the NIPH and the Mexico Social Security Institute (IMSS) in Mexico City.

The trial was carried out and evaluated in a gyneco-obstetrics hospital of the IMSS, which has a program to promote breastfeeding and has a rooming-in service in one of its units.

Project Background

Studies in Guatemala, the United States and South Africa on the participation of doulas have given positive effects (Sosa, et al., 1980; Klaus, et al., 1986; Kennell, et al., 1991; Hofmeyr, et al., 1991; Hodnett and Osborn, 1989). The most important contribution was the reduction of the use of anesthesia and analgesics during labor, cesarean sections and forceps. The presence of the doulas also shortened the length of labor. Similarly, the studies demonstrated that companion support during labor speeded up the mother's recovery, helped mother-child bonding, and reduced anxiety and depression in the first six postpartum weeks (Sosa, et al., 1980). In the most recent study (South Africa) it was also found that psychosocial support during labor had a positive effect on the start and continuation of breastfeeding (Hofmeyr, et al., 1991).

The following table, adapted from Klaus and others (Klaus, M., et al., 1992) summarizes the main findings of the studies that preceded the present work.

Effect of Social Support on Perinatal Outcomes: Meta-Evaluation of Five Randomized Oinical Trials

Author and Location Sample Significant Results Size Exp. Vs. Control

Sosa et al. n= 127 Decreased perinatal problems; Guatemala (1980) Exp= 32; decreased

Control= 95 length of labor; increased responsiveness of infant

Klaus et al. n=417 Decreased cesarean section Guatemala (1986) Exp= 168 rate; decreased length oflabor;

Control= 249 decreased oxytocin; decreased perinatal problems

Hodnett and Osborn n= 103 Increased oxytocin use; (1989) Exp=49 decreased need for epidural Canada/urban Control= 54


Kennell et al. ( 1991) n=416 Decreased cesarean USA/urban Exp=212 section rate; decreased need for

Control= 204 epidural; decreased oxytocin; decreased use of forceps; less maternal fever; decreased length of labor

Hofmeyr et al. (1991) n= 189 Increased coping during labor; South Africa Exp=92 increased breastfeeding; lower

Control= 97 perception of pain; decreased anxiety and depression after six weeks

The health benefits that these studies show for both the child and the mother led us to carry out a similar trial in a hospital in Mexico. Our research was not limited to replicating the earlier studies. We recruited more participants than in the earlier trials and, more importantly, we carried out the study under actual conditions in health services that attend to a large proportion of women in Mexico and Latin America. Furthermore, the doulas were in most cases retired nurses.

Finally, the study included a cost-effectiveness component that was much more detailed than in any earlier investigation on the subject.

Conceptual Bases and Hypotheses

Fear, tension, and solitude have a negative effect on a woman during labor and childbirth. These feelings are more intense in the first-time mother who knows nothing about the biological process or the context in which it takes place. There are a variety of mechanisms by which these emotional states affect labor (See Figure 1 ).

First of all, tension and anxiety increase the secretion of catecholamines which makes the uterine contractions less effective and, in consequence, prolongs labor (Ledennan, et al., 1987). Therefore, if the presence of a companion reduces anxiety it is reasonable to hope for a shorter labor, thus limiting the period during which complications may occur and making medical intervention less likely. Both circumstances reduce the risk of a cesarean section. Secondly, tension, anxiety and ignorance might make a woman lose control and start off the sequence of previously-described medical and surgical interventions.

A woman who is given adequate support during labor knows that what she is feeling is normal, that there is nothing wrong with what is happening to her and that labor is taking its due course. Consequently, she is much more cooperative; she is less likely to want an epidural anesthetic, she is not as impatient, and she will push harder during the expulsion period. All of these factors are also associated with less medical interventions, anesthesia, use of forceps, and fewer cesarean sections.

Furthermore, a woman who has taken an active part in the birth of her baby feels satisfied with the experience and has greater self-esteem. Both the physical health of the mother and of the newborn infant, as well as an


emotionally positive delivery, help to establish early and solid bonding between them as well as early and successful breastfeeding.

These conceptual bases permit us to put forth the following hypotheses for this study:

1) The constant presence of a doula during labor and childbirth reduces medical interventions and improves perinatal health.

2) Women who are accompanied by a doula feel they have greater control over their labor, are more satisfied with the reproductive experience, and, consequently, establish an earlier mother-child relationship. These positive effects increase breastfeeding and delay the use of formula and the time of ab lactation.

3) A visit by the doula-a key figure for the mothers-during the first hours following delivery makes the women more receptive to recommendations about breastfeeding.

4) A program that includes the support of a doula during labor and childbirth, as well as a postpartum visit, is cost-effective in comparison with the routine attention offered by the hospital.

Objectives

The following objectives were set for this study:

To evaluate the effect of the support of a doula during labor, delivery and the first postpartum hours on the physical and emotional health of the mother and the newborn baby, as well as on the proportion of women who breastfeed and the duration of exclusive breastfeeding.

More specific objectives were to:

1. Evaluate the effect of the program on medical interventions during labor and childbirth;

2. Evaluate the effect of the program on the length oflabor;

3. Evaluate the effect of the program on the woman's satisfaction with the childbirth experience; and,

4. Evaluate the cost-effectiveness of the program and compare it to the routine care offered by the hospital.

Study Site

In the IMSS Gyneco-Obstetrics Hospital No. 4 "Dr. Luis Castelazo Ayala" there are approximately 400 births a month, of which about 40% are to first-time mothers. This hospital has a traditional nursery and a small rooming-in service where some promotion is given to breastfeeding. About 25% of the births in the hospital are by cesarean section.


Women admitted to the hospital pass through different services. The process begins when the pregnant woman is examined in the Admissions Service where the doctor evaluates how far her labor has advanced. If labor is still not well established and the cervical dilatation is only 1 or 2 cm, she is kept under observation. If, however, she has already begun normal labor and the cervical dilatation is from 3 to 4 cm, she is immediately transferred to the Obstetrics Service.

The service has four maternity wards, each with six beds. In each ward the women are attended to by a team of doctors and nurses who work eight-hour shifts. When a woman is about to give birth, she is taken to a delivery room where another doctor and nurse attend to her and the newborn infant. In the case of a cesarean section, the woman is transferred to an operating theater. Once she has given birth, she sees her child for a few moments, a pediatrician gives the baby its first check-up and tells the mother about its health, sex, and weight.

Immediately following the birth, whether vaginal or by cesarean section, the mother is sent to the Recovery Service where she remains in observation for about two hours. She is then sent to the inpatient ward where her family may visit her.

The newborn infant may be sent to any of the following services, according to the pediatricians' evaluation and the availability of beds: Nursery, Rooming-in, Intennediate or Intensive Therapy. The babies sent to the nursery are visited by their mothers for feeding at predetermined hours. In the rooming-in service the newborns stay with their mothers. The treatment of babies in therapy services depends on their state of health.

In the case of a vaginal birth, the woman is discharged after approximately 24 hours; if the birth was by cesarean section, she remains in the hospital for about 72 hours.

During the short time the women spend in the hospital, a nurse talks to them for about 30 minutes as a group about breastfeeding.

Description of the Study

In keeping with the study' s hypotheses and to comply with its objectives, an intervention consisting of support to the first-time mother during labor, delivery and immediate postpartum period was designed and put into practice. The evaluation of the program was threefold: the effects on the health of the mother and child were measured by means of a randomized clinical trial, a method recognized as the best to make such evaluations (Schwartz, et al., 1980); cost-effectiveness was measured by a health economics study; and, women's perceptions and satisfaction were assessed by a qualitative study, as well as the health services personnel's viewpoints about the program Below we describe how the women who took part in the experiment were recruited, the profile and training of the doulas, and the methods applied to evaluate the results of the intervention.

Recruitment

Candidates for the study were first-time mothers who arrived at the health service with less than 5 cm of dilatation, without showing signs of any serious obstetrics disease, nor having indications for a cesarean section. The participants were recruited in the Obstetrics Unit from Monday to Friday starting at 8 a.m. The process was supervised by a previously-trained social worker who made a daily roll call of all the women entering the unit and who were then selected according to the study's criteria as to inclusion and exclusion.


The women who met the inclusion criteria were considered as potential participants and they were asked to give their informed consent to take part in the study; if they accepted they were asked to sign a specially designed form.

The women were then asked to respond to a brief questionnaire on sociodemographic aspects, the use of reproductive health services, habits during pregnancy, health background, expectations about breastfeeding and their emotional condition. The next step was to distribute the women at random according to a numbered list: an envelope was opened in which there was a paper showing to which group each women recruited for the study was assigned (see Figure 2). The random distribution of the women in the intervention and control groups guaranteed the equal distribution of known and unknown factors in both groups. This procedure, together with the fact that those evaluating the trial and analyzing the information were unaware of the status of the women included in the study, ensured the absence of bias, which is not the case with other evaluation methods. ·

The sample size-or the number of women to be recruited-was calculated on the basis of an expected increase of10%in the prevalence of infants breastfed one month after birth (from 45% to 55%). With an a of 0.05 (for a one-tailed test), a power of 80% and a 20% attrition rate, it was calculated that 370 women would be in each group (with an total= 740). The base prevalence of breastfeeding was taken from earlier studies done by IMSS.

The Intervention

When a woman was assigned to the intervention group she was introduced to a doula who accompanied her throughout labor, childbirth and the immediate postpartum period The doula did not leave the woman alone until she had delivered the baby. The program was designed based on the former interventions already mentioned and the personal advice of Dr. M. Klaus (Sosa, et al., 1980; Klaus, et al., 1986; Kennell, et al., 1991; Hofmeyr, et al., 1991; Hodnett and Osborn, 1989). The program consisted of five components:

1) Emotional support: The doula gave the woman continuous support during labor and delivery by talking to her, using encouraging and calming words. Furthermore, the doula acknowledged the effort being made by the mother and answered her questions while maintaining constant visual contact.

2) Information: The doulakept the woman informed about how her labor was progressing and, in words that were clear and easy to understand, about all the medical procedures.

3) Physical support: The doula encouraged the woman to adopt more comfortable positions. In addition, she told her how to relax (including visualization techniques) and to breathe. The doula gave the mother massages and held her hand when she thought it would help her.

4) Communication: The doula kept up a conversation so that the mother would not feel alone.

5) Immediate contact between mother and child: The doula encouraged the women to hold her baby immediately after birth and urged early breastfeeding, provided that the condition of the mother and the newborn permitted it.

The experiment continued in the period immediately after birth when the doula visited the mother in the inpatient ward. During that visit, the doula told the mother about the benefits of breastfeeding, how she might often encounter problems, as well as how to solve them to make sure that the breastfeeding was successful. At the

8 Wellstart International's Expanded Promotion of Breastfeeding (EPB) Program

same time, the doula did her best to answer the woman's questions. The information given in that talk was summarized on a small flip chart and a manual that was afterwards handed to the woman. When the newborn infant was with its mother, she was encouraged to hold it and give it the breast; in that way the talk could be illustrated with a practical demonstration. When the mothers did not have their babies with them, a doll was used to show the different positions recommended for successful breastfeeding. In the case of women who had cesarean sections, the talk was postponed for a day since most of them were feeling too much pain to pay attention.

At the end of the postpartum visit the breastfeeding manual was given to the woman and she was advised to read it carefully to help her with any of her doubts or difficulties regarding breastfeeding.

The visit lasted from 45 minutes to one hour and with it our intervention ended.

Training the Doulas

There has been ample discussion about the profile of the doulas by those who have developed these types of programs. In some studies, the doulas have been women from the community with a socioeconomic and cultural backgrmmd very similar to that of the women they helped during labor (Sosa, et al., 1980). While this is probably the best selection, few health institutions would agree to include such people among their staff.

One of the innovations of this study was that it was undertaken under conditions which, should the results prove to be positive, would permit the doulas to be recruited as part of the institution's staff. It was decided, therefore, that the doulas should be women who would not be rejected by the hospital and preference was given to retired nurses. In effect, it was considered that they would be very suitable for this type of experiment; they were women who were still young but old enough to allow the soon-to-be mothers to identify them with their own mothers; they had work experience in relation to pregnancy and childbirth; while no longer working, they were still energetic and wanted to continue being active. Furthermore, and although it was not thought to be indispensable, most of them had children of their own which could help them to understand the childbirth experience. However, we did not consider it essential for a doula to be either a mother or retired.

The doulas were recruited by means of a training course organized by the head nurse of the Dr. Luis Castelazo Ayala hospital who kept a list of IMSS retired nurses; some of those taking the course had previously worked in that hospital. All those on the list were contacted by telephone and invited to a meeting where they were given details of the project, the role of the doula was described and the training course explained. Twenty-four women attended the meeting.

Some women who presented themselves were not retired nurses. The decision to admit people other than retired nurses allowed us to bring together a more dynamic group that had the benefit of providing contact between women of different ages and at various stages of their lives. The course permitted us to make a selection from among the best participants to work with on the research project.

The training course was designed by the researchers responsible for the project, with the advice of a group of experts in childbirth education. It lasted for three weeks and was held in the hospital. It was a theoreticalpractical course and included instruction on the anatomy of a woman's reproductive apparatus, the physiology of pregnancy, the periods before, during, and after childbirth, breastfeeding, emotional aspects during labor and childbirth, obstetric complications and medical interventions, obstetric surgical procedures, neonatal procedures,


etc. Different teaching methods and a variety of activities were used to help develop the skills and attitudes desirable to fill the role of doula.

Before selecting a doula to work with the research project, she was tested in a number of ways: on her theoretical knowledge, her observation of a deliveiy and later comments and observations, her performance as a doula during two deliveries as observed by those responsible for the course, a personal interview, and a self-evaluation.

In general, throughout the course a change was observed in the participants as to their view of childbirth and their role as a support to the women: from a clinical perspective where medical routines were seen as the means of interacting with the mother and her recently-born baby, to a more human one where supporting the mother was the essential task. From twenty women who attended the course eleven were selected to work as doulas for twelve months.

During the field work, strategies were implemented to give continuous training to the doulas, to identify problem cases or uncommon or difficult situations that had to be resolved, and to find alternative solutions. In this respect the following activities were developed:

• A small but substantive library was prepared on pregnancy, childbirth, the postpartum period, care of the newly-born, relaxation techniques, massage, visualization, health conditions of women of childbearing age, etc., to which the doulas had everyday access.

• A presentation and discussion exercise was prepared about actual cases to provide the doulas with feedback and allow them to reflect on their own performance. The exercise began with the identification of a situation that was more complex or different from the routine, at times because of peculiarities about the birth, the physical or emotional state of the woman, the attitudes or behavior of doctors or nurses towards the woman or the doula, etc. These cases were discussed with the other doulas and with the field work coordinator.

• At monthly or two-monthly intervals meetings were held with the team of doulas in which doubts were clarified, the work reorganized, time allowed for questions and general comments about the work, and matters of logistics or administration were dealt with.

To put together a systematic collection of the doulas' work experience, when their participation in the hospital was over a final oral and written evaluation was made.

Evaluation of the Intervention

The intervention was evaluated in terms of its effects on the health of the mother and the child and on breastfeeding, its cost-effectiveness, and the perception of the woman, the doulas and health services staff. Below a description is given of the methods used to make each of these evaluations.

Effects on the Health of the Mother and the Newborn and on Breastfeeding

This evaluation was to measure the effects of the intervention on medical activities and procedures during labor and childbirth, the health of the mother and of the newborn, the emotional state of the mother, breastfeeding and

10 Wellstart Intemational's Expanded Promotion ofBreastfeeding (EPB) Program

the health of the baby a month afterbirth. (See Figure 2). The evaluation was made by two social workers who were responsible for getting the women of the intervention and the control groups to complete different questionnaires. The evaluators did not know to which group the women interviewed belonged.

The women's clinical records were revised to check variables relating to medical aspects of labor and childbirth and the condition of the newborn infant in the early morning following birth and before the women were discharged from the hospital.

Social workers (evaluators) also interviewed the women before they were discharged from the hospital, giving preference to those who had a vaginal birth since they were the first to leave. In that interview a check was made of the mother's emotional state and her feelings about the experience of giving birth. At the end of that interview an appointment was made with the mother to evaluate the results one month after she gave birth. The mother was made aware of the importance of that visit and she was asked for directions about how to reach her home. She was also given a note thanking her for taking part in the study, with a reminder about the date when she would be visited at home.

The home visit, one month after the birth of the child, was designed to check the health of the mother and of the newborn, with particular attention to breastfeeding. The evaluation team, when they finished their work at the hospital, made three or four home visits to women included in the study. Because of the special difficulties of getting around in such a huge and complex city, to make the home visiting program more efficient the visits were organized according to districts If the women were not at home when they called, the visits were reprogrammed as many as three or four times.

Cost-effectiveness

The increase in health services costs, the scarcity of resources, as well as the greater demand for more sophisticated health care (Frenk, et al., 1989), call for not only a revaluation of health priorities, but fundamentally for more efficient management of existing resources.

Before implanting a new health intervention, it must be evaluated not only in terms of its effectiveness but also in terms of the costs involved. Economics provides various tools to do this such as Cost-Benefit Analysis (CBA) and Cost-Effectiveness Analysis (CEA) (Mills, et al., 1988).

The application of economic coneepts to health services to estimate costs and to allocate and use resources based on efficacy3, effectiveness4

, and efficiency5 (Maynard, et al., 1990; Warner, et al., 1982; Gerand, et al., 1992) is well established. It is particularly to be recommended that the methodology of economics be applied when changes are to be made in the management of patients; this is especially important when conditions-such as

3Efficacy is the achievement of an intervention under ideal conditions.

4Eft'ectiveness considers the final result of the implementation of an intervention under real conditions; in health this impact of the strategy of care or action is measured as improvements in health levels.

5Efficiency refers to the possibility of reaching a determined result, with a greater optimization in the use of resources, or a less use of some resources, that is at a lower cost.


human resomces---may be costly, as is the case with this project with the introduction of the doula to care for the pregnant woman during labor.

The cost-effectiveness analysis is a method based on the systematic comparison of costs and effectiveness of alternative interventions in reaching a predetermined objective. This study included three different economic analyses: I) to measure the cost of each routine care-including the hospital program to promote breastfeedingand of the support provided by the doula during childbirth and immediately afterwards; 2) to compare the cost of care given to the intervention and the control groups; and, 3) to analyze variables of effectiveness in relation to the cost of routine care and of the program that includes the services of the doula.

To measure costs, a random sample of 3 72 woman was taken from the total number of women participating in the project (724). For each woman a determination was made of the time spent in the different hospital units, the number oflaboratory, X-ray, and other tests, the use of anesthetics, the type and amount of drugs and the use of the surgical room in the case of births by cesarean section. Later, a calculation was made of the cash equivalent of each item by taking the average cost of each hospital activity.

Included in the estimate of the cost of the program with doulas were salaries, the training course, stationery, and the printing of promotion leaflets on breastfeeding. The cost of facilities was not considered since it is included in the cost of hospitalization which was the same for both alternatives evaluated. To obtain the program's average cost, the total cost was divided among the total number of hours spent by the doulas with the women. In estimating the cost of the hospital breastfeeding program the salaries of the staff working on it were included.

Once the costs of the care provided to each of the 372 women in the study were calculated, the average costs for the intervention and control groups were estimated; these figures were compared by using non-parametric median tests such as the Wilcoxon and Kruskal-Wallis.

The effectiveness units were obtained by means of the information in the questionnaires, as well as a review of their clinical records. The effectiveness of the intervention and control groups was compared and significant differences estimated. Finally, the total unitary costs for cases and controls were estimated and were then compared to the effectiveness units.

Perception and Experiences of the Women, the Dou/as, and the Hospital Staff (Qualitative Study)

To learn about the perception and experience of the women taking part in the study, as well as the perspective of the doulas and hospital staff, a qualitative study was undertaken. To take a close look at the subjective opinions of the chief protagonists in this project in-depth interviews were held and observations made, using guidelines especially prepared for the purpose. Three researchers with expertise in qualitative methodologies were responsible for this evaluation; they prepared a first version of the guidelines that were tested in pilot interviews and observations, and adjusted according to the results.

Twenty women were interviewed (ten in hospital and ten at home), as well as eight doulas and six hospital staff (three nurses and three maternity ward physicians). Those interviewed and the size of the sample were not defined on a statistical representative basis but according to another criterion used in qualitative studies: the "saturation point" (Glaser and Strauss, 1967).

12 Wellstart Intemational's Expanded Promotion of Breastfeeding (EPB) Program

The "theoretical saturation" is a conventional criterion of qualitative methods that serves to determine the moment in which field work and the collection of information should be suspended. Initially proposed by Glaser and Strauss, the criterion consists in identifying the moment when the information begins to become repetitive. To permit this, the information must be analyzed as it is being collected thus permitting theoretical or typological representation In other words, the researcher obtains information on the different "types" of actors participating in the process, or on their experiences in relation to the subjects being researched (Glaser and Strauss, 1967).

In selecting the sample of women to be interviewed account was taken of some basic characteristics such as age, civil status, schooling, and medical history. The women were asked to give their informed consent to take part in that specific study. Half of the women were accompanied by doulas and the other half acted as controls, just as in the global study. A few hours after childbirth the in-depth interview was held with the woman and, when it was finished, an appointment was made for a second interview at her home six weeks later.

The in-depth interviews were of the "open answer" type, and were conversational. Briefly, the guidelines for interviewing the women included four major topics: the general reproductive experience, mainly focused on the support of her companion or another family member or friend; the childbirth experience; the relationship between the woman and the doula and/or the clinic personnel; and its context. In the home interviews, the same topics were raised and one more was added: the experience with breastfeeding and the support received in this respect.

A previous appointment was made for the interviews with the doulas as well as the clinic personnel. The interviews with the doulas dealt basically with two aspects: their perception of the resistance they met in giving support to the women during childbirth and the hours immediately following, and their experience with the training and with the work in the maternity ward (fatigue, routine, initiative, and creativity). The interviews with the doulas were held twice during the field work; half way through and at the end of their participation in the hospital.

The interviews with the hospital staff were focused on those physicians and nurses who had been present while the doulas were working. This made it possible to find out what they thought about the doulas • activities and the resistance that the latter encountered in carrying out their work, with particular emphasis on the staff's own role in the delivery room.

As part of the qualitative study, six observations were also made oflabor and childbirth using the "shadow study" technique. This is a method in which the observer is present at the event, making careful and precise notes about everything that is said or done at the scene that was previously identified as being the subject of the study. In general it may be said that this teehnique corresponds to that which methodology manuals conventionally define as participative observation with a non-identified observer.

The observations were made in the maternity ward and the delivery and surgical rooms. They were made during the final stage of the field work. The observations were programmed without notifying either the staff or the doulas. In some cases the doulas were included while in others observations were made of routine care activities.

As to the qualitative study, the interviews were recorded and transcribed. Later, these texts were converted to ASCII and finally transferred to the Ethnograph software. Once the texts were put into column form, they were printed in order to be coded. The observations were transcribed for later analysis.


Results

For the study 3,081 women were selected of whom 728 met the inclusion criteria. Only four of them did not agree to take part in the study. Therefore, 724 women were recruited, 363 (50.1%) forthe control group and 361 (49.9%) for the intervention group (Table 1). There was a small attrition rate: we were able to evaluate 723 (99.8%) in the immediate postpartum period, and 655, or 90.5% of those recruited at the interviews that took place one month after birth. In other words, we had an attrition rate of 9.5%, with no significant differences between the intervention and control groups. It is important to point out that, when calculating the size of the sample, a loss rate of 20% was estimated.

Table 2 explains the reasons for these losses. The most common was that some of the women gave wrong addresses when :filling in the baseline questionnaire, or they later moved to other addresses. Less than a quarter of the losses were due to the women never being at home when the interviewer called, in spite of up to four visits being made. Slightly more than 10% of the losses were due to some women refusing to continue taking part in the study after being discharged from the hospital.

Effects on the Health of the Mother and the Newborn Infant and Breastfeeding

In Tables 3-5 details are given about the groups when they entered the study. The variables for comparison between the intervention and control groups come from the screening and base line questionnaires. This analysis was designed to confirm that random sampling had produced two homogenous groups.

The results of the intervention on childbirth and institutional care, as well as on the conditions of the newborn, on breastfeeding and on the mother's postpartum emotional state are given in Tables 6-11. The results come from the postpartum interview questionnaires, from the mothers' and newborns' clinical records, and from the home visit one month after birth.

Table 3 presents socioeconomic characteristics of the women in both groups at the time ofrecruitment. It can be seen that most of them were young, with more schooling than the country's average, with a medium socioeconomic level, and with a partner. The results show that there were no significant differences in any of the recorded variables.

Table 4 gives the reproductive history of the women in the study. The great majority of them were first-time mothers; the rest were women who had previous cesarean sections or abortions but with no labor or childbirth experience. These characteristics are not representative of the women in the hospital but reflect the selection in accordance with the inclusion criteria in the study. Attendance at prenatal care services was very high, a foreseeable result given that these women all had access to social security services. The pregnancies were planned in about 80% of the cases. None of these variables presented significant differences between the intervention and control groups. The groups were also similar as to information about the birth and it is worth noting that relatively few women said they were informed about it. No differences were found in the average gestational age.

The only variable that showed significant differences between the intervention and control groups was that concerned with previous breastfeeding among women who already had a child (p<0.0002). The proportion of these was low among all the women in the study, but those in the group with doulas had breastfed less often th.an those that had received routine care (Table 4).

14 Wellstart International's Expanded Promotion of Breastfeeding (EPB) Program

As to the women's emotional condition state on being admitted to the maternity ward, no differences were found as to nervousness, fear, or pain (Table 5). Approximately a third of the women in both groups said they were not nervous or afraid This result was unexpected considering that for most of them it was the first time, that is, they did not have the biological experience of labor and childbirth and did not know what was about to happen to them. In both groups the vast majority reported a great deal of pain and only a small proportion (8% of the total sample) said they felt none.

In conclusion, from the comparison of the baseline data of the women participating in the study it is possible to assert that randomization was efficient, since it produced two homogenous groups as to their socioeconomic level, reproductive history, and emotional state upon entry.

Table 6 shows the effects of the program on the birth process, with particular emphasis on medical interventions. There were no statistically significant differences in the proportion of normal deliveries and a high proportion of cesarean sections (25.5% in the whole group), which was substantially greater than that reported in the hospitals where other studies with doulas were undertaken (Sosa, et al., 1980; Kennell, et al., 1991; Hodnett and Osborn, 1989). There was very little use of forceps. Peridural anesthesia was used in the great majority oflabors (85% of the total sample). This proportion shows that it is practically a routine procedure, and undoubtedly is independent of the variability in labor and the pain threshold for each woman. In comparing these variables in the control and intervention groups no statistically significant differences were found, although a tendency was confirmed towards more medical and surgical interventions in the control group.

It was not possible to measure the use of oxytocics to induce or control labor because this was not registered in most of the clinical records. In fact, the insertion of a venoclysis and a drip with oxytocics in different doses is practically routine in the hospital where the study was made.

These results show that, unlike previous studies (Sosa, et al., 1980; Klaus, et al., 1986; Kennell, et al., 1991; Ho:fineyr, et al. 1991; Hodnett and Osborn, 1989), the intervention did not change rigid institutional practices that have little relation to the peculiarities of the women and their labor. In effect, in these studies the presence of the doula significantly reduced the frequency of the interventions, except the use of forceps, according to the meta analysis prepared by Keirse et al (1989). The lack of positive effects, in itself disappointing, allows some general remarks about the external validity of previous studies (see the sections on Discussion and Conclusions).

Table 7 contains data on to the median length oflabor and hospitalization. (The mean length oflabor was not compared since the data did not show a normal distribution). When comparing the intervention group with the group receiving routine care a cle·ar significant statistical difference appears in the length of labor (3. 83 hours in the intervention group and 4.8 hours in the control group). This difference persisted when analyzing the total time spent in the hospital, although it was within the limits of statistical significance.

The presence of the doula reduced the time spent in labor in this research in a proportion similar to that achieved in earlier studies (Klaus, et al, 1992). The duration of this stage in absolute terms was shorter in the present study than in those that preceded it, probably because the women were recruited with less than 5 cm of dilatation, while in the others a more restrictive inclusion criterion was applied (less than 3 cm) (Sosa, et al., 1980). The shorter time may also have been influenced by the hospital's generalized use of oxytocics.

All the women were given oxytocin, according to information provided by our field staff, even though we lack the data to demonstrate this (see above). This finding shows that a shorter labor time in this hospital did not modify the use of ocytocics, whose dripping was begun when the woman entered the maternity ward. In other


words, drugs to induce labor appeared to be indicated without taking into account the spontaneous dynamics of the labor itself. Reducing the length of labor and time spent in the hospital has important implications as to institutional costs (See results of the cost-effectiveness study).

In Table 8 the conditions of the newborn are presented. Thus, an Apgar of less than eight (values considered as indicators of fetal distress) at one minute and at five minutes after birth was very rare in both groups, with no differences between them. Nevertheless, clinical records registered some level of fetal distress and meconium in 18% and 19°/orespectively, without any differences between the groups studied (Table 8). In fact, the values of these last two variables were so similar that they seem to indicate that the clinical diagnosis of fetal distress was made only when meconium was present. The Apgar did not seem to be taken into account in making this diagnosis or in guiding neonatal treatment.

Table 9 describes the mother's emotional state during childbirth and immediately afterwards. Women in the intervention group had much greater control over their experience than their counterparts in the comparison group. This result supports one of the hypotheses of the present study. Pain during labor did not show any difference between the two groups. As to anxiety, no differences were found either. Though Spielberger's test has been validated in multiple studies, including a Spanish version (Spielberger, et al, 1971), in a earlier study by the same research group it was found that it limited validity when comparing its results with the findings of the qualitative study with women in the same sample (Langer, et al, 1996), In spite of being aware of these limitations, we used the test because it is practically the only one available.

Table 10 gives details about newborn feeding. It can be seen that only 9% of the total sample began breastfeeding in the hours immediately following birth. This percentage is really low considering that the hospital is clearly in favor of breastfeeding and has a rooming-in unit. The intervention did not alter institutional norms that delay breastfeeding.

The :frequency of exclusive breastfeeding one month after birth was significantly higher in the intervention group. We consider this to be an important achievement of the program since it was one of the main objectives of the study, and there are few effective methods to increase the prevalence of exclusive breastfeeding (Inch, et al., 1989). However, it must be admitted that the proportion of exclusive breastfeeding was relatively low because of the large proportion of full breastfeeding-giving mothers' milk together with teas and/or water (37% of the women in the study).

Feeding on demand was most common in both groups, without any difference between them. All behavior recommended to promote breastfeeding (care of the nipples, hygiene, etc.) was significantly better in the intervention group, which clearly shows the positive effect of the talk on breastfeeding given in the hospital to the women in that group. This finding is an affirmative response to one of the hypotheses of the study: the ready acceptance by the women in the intervention group of the recommendations on breastfeeding and the conditions that favor it.

Also studied were the reasons why breastfeeding was interrupted or supplemented in both groups (44% in the control group and 38% in the intervention group) (Table 11). Reasons studied included problems with the nipples, return to work, the mother's or the newborn's sickness, perception by the mother that "there was not enough milk" or ''the baby didn't like it'', a recommendation by some family member or by the doctor, etc. There were significant differences in favor of the intervention group in respect of"the doctor's advice" (OR= .50; IC (95%) .27-.95), "the milk dried up" (OR=2.76; IC (95%) .99-7.65) and "the mother was hospitalized" (p=0.07).


These differences seem to imply that the women in the control group supplemented their milk with a formula because of reasons based on popular beliefs about breastfeeding, or because they had been given recommendations by doctors who, unfortunately, too often and with little foundation, recommend a supplement. The women in the group with doulas appear to have been better prepared to ignore this advice; they only added a supplement when health problems arose.

Cost-effectiveness

To measure costs a determination for each woman was made of the time spent in the obstetrics and general hospital services, how many laboratozy, X-ray, and other tests were made, the use of anesthesia, the type and amount of medicines and the use of operating theaters. To do so information was taken from the patients' records.

A calculation was then made of the cash equivalent for each item used. In this case the institution itself provided average costs for each relevant activity. Thus, for example, average costs were used for: hour/hospital, laboratory, X-ray, and other tests, and the time spent in operating theaters in the case of cesarean sections. These included both direct costs of human resources and materials as well as the indirect costs. In the case of medicines, wholesale purchase prices were used and, when these were not available, the market prices charged to pharmacies were used (Table 12).

In estimating the cost of the doula program account was taken of the amount spent on salaries, the training course, and on stationezy and printing the leaflets which were the most costly components. The cost of installations was not considered since it was included in the cost of hospitalization which was the same for both alternatives. The total cost was divided between the total number of hours/doula/woman, thus obtaining the average cost of the program.

To estimate the cost of the hospital's breastfeeding program the salaries of the staff concerned were included; excluded were training and stationery costs as they were not applicable; the cost of hospital installations was not included for the reason mentioned above. Once the cash equivalents of the activities and materials were obtained for each woman, the cost variables were established. The effectiveness units were obtained by means of the different questionnaires of the project as well as by reviewing clinical records. The design of the study----randomiz.ed clinical trial-allowed significant differences to be detected between the intervention group (with doula) and the control group (without doula).

The cost-effectiveness analysis produced the results given below. As to costs, the program with doulas requires personal attention to be given to the woman who is about to give birth; therefore, the human input is the most important The average number of hours doula/woman was 4.39 from her entzy into the labor room until the baby was born, and an extra hour immediately afterwards when the doula's task was to encourage her to breastfeed the infant. The highest costs, therefore, were salaries, although there was also an investment in training and printing. The average cost of the program was $104.51 per woman (Table 13).

For the hospital's breastfeeding program the key input was also human given that the main endeavor was the group talk with six or seven women in the 38th week of pregnancy, and another talk to groups of 20-25 woman immediately following childbirth. Hardly any use was made of items such as stationery. The cost of the talk per woman was $4.48. The program coverage was 46% in the case of the intervention group and 4 7% in the control group. The average cost of the breastfeeding program per woman was $2.56 and $2.13 respectively (Table 14).

ResearchMonograph 17

Another variable analyzed in terms of costs was the time spent in the hospital; this was significantly shorter in the intervention group than in the control group because there was a significant reduction in labor time (approximately 20-25%) and a reduction of 12% in the total time spent in the hospital (Table 14).

The average cost of medicines was slightly higher in the intervention group than in the control group, although this increase was not significant from the statistical point of view. The average costs of laboratory tests and time spent in the operating theater were lower in the intervention group, although again without statistical significance.

Even though there was a significant reduction in the most important cost, which is hospitalization, the total costs for both groups, once the breastfeeding and doula support programs were included, were 5% less in the intervention group. This reduction was not statistically significant mainly because the total costs of the doulas program and routine care were very similar (Table 14).

Given the similarity in the costs of both programs, the difference between them could only be established on the basis of the variations in effectiveness. The variables that were significantly different in favor of the intervention group were those already mentioned: differences in the length of labor and hospitalization, as well as the degree of control of the women during labor and exclusive breastfeeding, which increased by 71 % in the group with a doula.

These results signify that, with similar costs, the experimental program was more effective than the routine care. It may be concluded, therefore, that the doulas program was cost-effective (Table 15).

Perception and Experiences of the Women, the Doulas, and the Hospital Staff

The in-depth interviews produced an enormous amount of useful information. Here we shall mention only the most relevant :findings. In the interviews with the women in the hospital they were asked about their experiences in the maternity ward and what they thought about the support given by the doula. When they were admitted to the hospital women felt that ''they put themselves in the hands" of the institution, particularly of the doctors, and that they were not entitled to ask questions or to complain; indeed, they were not prepared to do so ("they're the ones that know''). Furthermore, they felt that if they complained or asked something they are "a nuisance" and, in consequence, they would be mistreated or ignored. This indicates that the women have very little control over what happens to them when in labor.

In spite of the above, the great majority of the women said they had received adequate treatment and that they were satisfied with it. In this respect there were differences between the two groups: the women who had been accompanied by a doula, when repeatedly asked, were prepared to say when they were not happy about some aspects of the care they received.

The women in both groups said they felt very afraid. This contrasts with the answers given to the questionnaire where a considerable proportion said they had felt very little fear during labor and childbirth.

In the interviews questions were put to the women about some concrete aspects of the care provided in the maternity ward such as, for example, peridural anesthesia It was very important to discover that the women were not asked whether they would like a peridural anesthesia and they did not ask for one: it was simply given to them and, often, they were threatened to make them keep still during the procedure ("if you move, it will be your fault if your baby is pricked").


The women in the intervention group had a very positive opinion of the doula as someone who gave them information, calmed them, encomaged them, explained how the labor was progressing, and talked to them. These women also showed a marked difference from those in the control group as far as self-esteem was concerned. Those who had been accompanied by a doula evaluated their own behavior during labor and childbirth (they added to the doula's comments), they felt they were active participants in the process, unlike the women in the control group who felt that the doctor had done everything that was necessary for the baby to be born.

The home interviews concentrated on breastfeeding. It was found that the intervention of the doula during the talk and the support she gave them were of help. However, for the women in both groups the key element for successful breastfeeding was the support of the partner and of other family members.

The interviews with the nurses showed that they resented the presence of the doulas: they did not think that their presence made their own work any easier and, at the same time, they looked on the doulas as possible competitors. Furthennore, they found it bothersome that the women with support asked more questions and demanded more attention. In one way or another the presence of the doula broke the control they exerted over the patients.

As to the doctors, they did not pay much attention to the doulas' presence. Unlike the nurses, they did not feel threatened by them. The doctors blamed the large number of patients and the dynamics of the service for the limited amount of time they could dedicate to the women and saw the doula as someone who was of help in this respect.

A careful analysis of these results, and their contrast with structured mechanisms, will undoubtedly lead to a comprehensive understanding of the aspects being studied.

Discussion and Conclusions

The movement away from the home and into the hospital as the place to give birth has undoubtedly led to a better outcome for complicated deliveries; the price of this movement has been dehumanized treatment and excessive intervention of normal labors and childbirths, which are the most common. Many people believe that fear, pain, and anxiety are increased in a mechanized clinical environment in which care is provided by people unknown to the woman, with adverse consequences for the birth process. The woman in the hospital is exposed to all the risks implicit in a series of interventions; one unwanted activity leading to another.

Outstanding among all the changes that have been considered to return childbirth to its normal environment is to provide the pregnant woman with a supportive birth companion whose presence makes childbirth less threatening and more controllable. The people who have been considered as possible candidates, whether in practice or in studies on the matter, include clinical staff (doctors and nurses), the partner or other family members or friends, and people specially trained for the role. Included in the last-mentioned category are the doulas; the effects achieved with the participation of the doulas in a key role as attendants are those that have been most systematically evaluated, through rigorously designed studies (randomized clinical trials) (Klaus, et al., 1993).

This study is added to the short list of earlier experiments. In many aspects, the present research is a duplication; however, some new components have been added that provide elements for reflection about the challenges of the general findings of previous studies.


The aspects of the studies ofKlaus, Kennell, Sosa and others (see references) that are included in this project are essential: the definition of support during labor, the type and contents of the training given to the doulas, the epidemiological design to measure the effects of intervention, and the resulting variables. The elements that this project has added to deepen the understanding of the subject are: carrying out the study in a hospital that offers medicalized and highly technical care, representative of the type of institutions in which a large proportion of women in Mexico and Latin America give birth; the recruitment of a larger sample than in earlier studies; the selection of retired nurses to be trained and undertake the role of doulas; measuring the cost-effectiveness of the intervention; and, carrying out a qualitative study to learn about the perception and experiences of the women, the doctors, and the nurses concerning the birth and the care received or offered, respectively.

A highly motivated research and field group was responsible for the study which was undertaken with the full scientific rigor proper to the chosen design. However, the results obtained were more limited than in previous studies. Below various hypotheses are discussed which could explain these limited effects.

1) The group in this study was less vulnerable to hospital conditions

According to Keirse et al. (1989), the appropriate cultural care offered by the doula may counteract the negative effects of the unknown and :frightening hospital environment. This mechanism was considered as having great weight in the studies done in Guatemala, in which particular emphasis was placed on the doula belonging to the same ethnic group, speaking the same language and coming from the same cultural background as the women (Sosa, et al., 1980). This was not the case in our study, in which the women were slightly older than the Guatemalan study population, came from urban areas, had a medium-level educational and socioeconomic status, and were all of them rather far removed from their indigenous and/or rural roots. Fear and anxiety came from being ignorant about labor and childbirth and the hospital routine rather than from the cultural clash between their beliefs and customs and the hospital environment. This may have made the women in our study less vulnerable and, therefore, less susceptible to being helped by the intervention.

2) Characteristics of the intervention

The possibility should be considered that the intervention in Mexico might have been less intense, of lower quality, than those of earlier studies. We believe, however, that this was not the case: the doulas were very highly motivated women, most of them were themselves mothers, they received training that exactly followed the model recommended; and, they offered good quality human support with the components described in the other studies; they did not leave the women until delivery had taken place and they even visited them to talk about breastfeeding before they were discharged from hospital. One aspect that, however, might have contributed to the limited effects was the shorter length oflabor in our study (i.e. less contact time between the woman and the doula). This shorter time was due to hospital requirements for admitting patients (with not less than 5 cm of dilation) and the almost universal use of oxytocin, on which our study had no influence.

3) Methodological limitations

Potential methodological limitations must be considered when assessing an intervention study. In this case nevertheless, the care with which the experiment was carried out makes this unlikely. First of all, we evaluated the program by means of a randomized clinical trial, which is the best way to measure the effects of an


experiment. Great care was taken with all the aspects that ensure quality in this type of study: randomizing and evaluation were blind; women were asked to give their consent before randomization; the characteristics of the intervention and control groups showed no differences (i.e. randomization was effective); the sample was large enough; the percentage of losses was similar in both groups; and contamination between the women with and without a doula was avoided as far as possible. Our study shared some limitations with earlier ones: it was impossible to prevent the clinic's staff from being aware of the experiment, and we did not measure the effect this might have had on their behavior. Our study, however, added elements for understanding this effect by means of the qualitative study, which confirmed that the doctors were not really aware of what the doulas were doing. Based on these :findings we may consider it unlikely that the intervention could have affected their behavior in respect of either of the two groups. The irritation that the doulas produced among the nurses could have had some effect on the outcomes but this was not measured.

4) Little effect of the experiment on the study's intermediate variables

With our experiment we were not able to achieve a positive change in fear and anxiety (intermediate outcomes) though the sense of being in control of labor was higher in the intervention group. The limited effect was not translated into a reduction of the number of medical interventions in a hospital with rigid routines. On the other hand, the program, in keeping with the study's hypotheses and conceptual bases, was able to favorably modify the woman's experience and thus achieve more efficient labor and more successful breastfeeding.

5) Rigid medical and surgical practices in the study site

The first mechanism suggested by Keirse et al. (1989) to explain the effect of the doulas on hospital interventions is that by lessening fear, pain, and anxiety (or by giving the woman more control over her labor) time spent in labor is reduced and, in consequence, so is the need for oxytocics, anesthetics and cesarean sections. In our project, the presence of the doulas increased the woman's control and reduced labor time. In addition, the interviews with the women also confirmed favorable effects in respect to anxiety, fear, and distress. However, in Mexico the benefits stopped there: these changes were not reflected in the behavior of the hospital staff or in fewer interventions.

This may be due to the characteristics of the hospital where the experiment was held. What differences are there between our hospital and others in which the results were clearly positive as to medical-surgical interventions? Differences are obvious between the IMSS hospital and the American ones. The hospital that is probably closest to the one in our study is that in which Klaus, Kennell and Sosa worked in Guatemala (see references). In effect, the number of births per day was similar, as was the medical care provided with little attention being paid to the peculiarities of each patient, forbidding the presence of the patient's partner or family members, the fact that it was also a social security hospital, etc. However, on reviewing key indicators important differences appeared. In general, there were many more medical interventions in Mexico. For example, the Epidural anesthesia was used in 23% of the women in the control group in Guatemala and in 87% in Mexico; the cesarean sections corresponded to 13% in Guatemala and 27% in Mexico; oxytocin was used in 13% of the controls in Guatemala and in all women in Mexico; and, showing a contrary tendency, the use of forceps was 25% in Guatemala and only 3% in Mexico.

When a procedure is indicated in almost 90% of cases (i.e. epidural anesthesia and oxytocics) it is obvious that it is a routine and, therefore, difficult to modify. In our study cesarean sections were also frequent, supposedly


for ''technical" reasons, prolonged birth, in a large number of cases. Besides these kinds of "clinical" conditions, other reasons have been demonstrated to underlie the true "epidemics" of cesarean sections in Latin America. We were not able to influence this practice. Finally, very little use was made of forceps, no doubt because it is thought that if the fetus does not descend properly labor should be interrupted by a cesarean section. The greater efficiency with which the mothers pushed, which might have avoided the use of forceps in Guatemala, was not enough to reduce even further the already low figures we found in our study. With regard to the studies carried out in the United States and South Africa, we lack the detailed information we have on the Guatemala study to allow a comparison to be made between medical interventions in the institutions concerned and the hospital in Mexico.

Our experiment achieved effects with respect to the mother's emotional state and breastfeeding similar to the South African study (Klaus, et al., 1992). Thus, both programs succeeded in strengthening the sensation of greater control in the mother helping to make breastfeeding more successful (in both studies exclusive breastfeeding was more frequent; in the South African study effects were also achieved on feeding with no set time as well as on reducing feeding problems). This result is very positive; in fact, there are very few interventions that have produced an objectively demonstrated positive effect on breastfeeding (Inch, et al., 1989; Perez Escamilla, et al., 1994). Finally, in Mexico we did not measure indicators of the relation of the mother to her newborn or to her partner.

6) Differences between both groups in expressing their needs and concerns

Another hypothesis put forward by Keirse et al. (1989) is that, while they showed no changes as to fear, pain and anxiety, the women with doulas complained less and, therefore, received less medical treatment. The results of the qualitative study seem to indicate that in this experiment the contrary was the case: the doulas stimulated the women to take an active part in the labor process and to express their doubts and concerns, which may have led to more medical interventions. In fact, when they showed signs of distress, the women in labor were given very brusque answers by the hospital staff and, in some cases, they were even threatened: the fetus would die if they did not calm down, any complication would be their fault, etc. This undoubtedly happened more often in the group without doulas and it was probably more "effective" than their presence to reduce signs of anxiety in the about-to-be mothers.

7) Problems in measuring the results

It is very unlikely that there was anything amiss in measuring the results of medical interventions which were precise and in most cases adequately registered in the clinical records. We found, however, evidence of very deficient data regarding the health of the newborn (see above -Apgar measurements and fetal distress). The errors, in any event, are unlikely to have caused any modification in the tendency of the differences between the two groups evaluated. There may have been measurement problems in evaluating the women's emotional state. In fact, the structured questionnaires are instruments that are very often necessary but definitely not ideal. A proof of their limitations is that while no quantitative results were demonstrated regarding fear and anxiety for example, the interviews clearly indicated that the women in both groups felt distress, fear and pain during labor. While qualitative evaluation cannot establish differences, it does allow us to suspect a limited validity of the structured questionnaires. The variable "satisfaction with care received", for instance, is very difficult to measure by means of a questionnaire, above all if it is completed in the hospital. In effect, it is clearly demonstrated that


the information obtained has a very limited validity because of the bias deriving from the fact that those interviewed give the answers they think are expected of them.

In conclusion, of all the hypotheses under consideration, we think that the characteristics of the hospital and of the women admitted to it are those which best explain the limited effects of our study compared to the others. However, positive effects on the emotional state of the mothers, length of labor, and duration of exclusive breastfeeding were found We can say that the participation of doulas is cost-effective and can be recommended to those responsible for clinical services. To increase its cost-effectiveness, consideration should be given to applying the program in hospital units with less inclination towards interventions and stereotyped interventions (increase in effectiveness). To reduce costs, consideration might also be given to variations of the program such as that each doula looks after two women simultaneously, in adjoining beds in the maternity ward.

I FIRST LABOR I

~ HOSPITAL CONTEXT

FIGURE 1

CONCEPTUAL BASES AND HYPOTHESES

FEAR &

ANXIETY

I I

DOU LA REVERSES

THE PROCESS

ADRENALINE

LOSS OF ~ -y CONTROL

LACK OF COOPERATION

=!

MORBIDITY

/

MATERNAL

---------1~PERINATAL

'f' MEDICAL MORBIDITY

INTERVENTION ~~SELF ESTEEM

L----------'~ BREAST-FEEDING

\ 'f' HOSPITAL

\ COST

'f'sATtsFACTION

RECRUITMENT SCREENING

---------~ WOMENWIIO MEET

~~~~~ ~ REQUIREMENTS

WARD ~ WOMEN WHO DO

NOT MEET REQUIREMENTS

" EXCLUDED

FROM STUDY

FIGURE 2

STUDY DESIGN

BASELINE

~-------

INFORMED CONSENT

RANDOMIZING

SOCIODEMO [-~ES ,::--1\:_.. INTERVENTION -=J GRAPHIC ~ --,/ CONDITIONS & ~--

REPRODUCTIVE '\JI NO I lllSTORY I

,, EXCLUDED

FROM STUDY

EVALUATION

/ l ~---------- ---·----- -~------

CLINICAL RECORD

IIOSPITAL VISIT - HOME

VISIT

TABLE 1

FLOW OF PATIENTS

WOMEN CANDIDATES AGREED TO IMMEDIATE HOME SCREENED TAKE PART POSTPARTUM EVALUATION

EVALUATION

TOTAL 3081 728 724 723 (99.9%) 655 (91.0%)

EXPERIMENTAL 361 361 (100.0%) 332 (92.5%)

CONTROL 363 362 (99.7%) 325 (89.5%)

TABLE2

REASONS FOR LOSS OF PATIENTS

REASONS N %

[WRONG ADDRESS 24 35.8

CHANGE OF ADDRESS 16 23.9

NEVER AT HOME 11 16.4

REFUSED TO CONTINUE PARTICIPATING 8 11.9

STILLBIRTHS AND PERINATAL DEATHS 4 6.0

OTHERS 4 6.0

TOTAL 67 100.0

TABLE3

SOCIODEMOGRAPIDC CHARACTERISTICS OF THE WOMEN INTERVENTION AND CONTROL GROUPS

CHARACTERISTICS GROUP TOTAL SIGNIFICANCE I c

AGE 22.5 22.9 22.7 NS (X)

SCHOOLING Primary 13% 12% 12% NS

(46/361) (44/363) (90/724)

High school 76% 76% 76% NS (276/361) (278/363) (ss2n24)

University 11% 12% 11% NS (39/361) (43/363) (82/724)

SOCIOECONOMIC LEVEL Low 13% 12% 12% NS

(46/361) (44/363) (90/724)

Medium 87% 88% 88% NS (315/361) (319/363) (634/724)

LIVES WITH PARTNER 88% 88% 88% NS (319/361) (320/363) (639/724)

SOURCE: BASE LINE QUESTIONNAIRE

TABLE4

WOMEN'S REPRODUCTIVE HISTORY INTERVENTION AND CONTROL GROUPS

CHARACTERISTICS GROUP TOTAL I c

FIRST BIRTH 93% 91% 92% (336/361) (329/363) (665/721)

!PRENATAL CARE 99% 99% 99% (357/361) (360/363) (717/724)

!PREVIOUS BREAST- 62% 97% 82% FEEDING(l) (15/24) (31/32) (46/56)

!PLANNED PREGNANCY 79% 80% 79% (286/361) (289/363) (575/724)

INFORMATION ON 55% 62% 59% CHil..DBIRIB (201/361) (224/363) (425/724)

GESTATIONAL AGE 39.1 39.2 39.1 (WEEKS) X

(1 )ONLY FOR WOMEN WHO HAD ALREADY HAD A CIIlLD


SIGNIFICANCE

NS

NS

PL .as :te

NS

NS

NS

TABLES

WOMEN'S EMOTIONAL STATE UPON ENTERING THE STUDY INTERVENTION AND CONTROL GROUPS

EMOTIONAL GROUP TOTAL SIGNIFICANCE STATE I c

NERVOUSNESS A lot 42% 45% 43% NS

(150/361) (161/358) (3111749)

A little 28% 28% 28% (102/361) (99/358) (201/749)

None 30% 27% 29% (109/361) (98/358) (207/749)

FEAR A lot 40% 40% 40% NS

(141/353) (144/362) (285/715)

A little 31% 36% 34% (111/353) (129/362) (240/715)

IN one 29% 24% 26% (101/353) (89/362) (190/715)

!PAIN A lot 78% 72% 75% NS

(281/361) (262/362) (543/723)

A little 15% 18% 17% (55/361) (66/362) (121/723)

IN one 7% 10% 8% (25/361) (341/362) (59/723)


TABLE6

CHARACTERISTICS OF LABOR AND CHILDBIRTH INTERVENTION AND CONTROL GROUPS

CHARACTERISTICS GROUP TOTAL OR I c

NORMAL DELIVERY 73% 69% 71.4% 1.22 (262/357) (247/356) (509/713)

* FORCEPS 2.8% 3.4% 3.1% .79 (10/357) (12/356) (22/713)

* CESAREAN SECTION 24% 27% 25.5% .85 (85/357) (97/356) (1821713)

* EPIDURAL ANESTHESIA 83% 87% 85% .76 (295/355) (302/346) (597/701)

* OR ADJUSTED FOR AGE AND CM OF DILATATION

SOURCE: THE WOMEN'S CLINICAL RECORDS

LC. (95%)

(.87 - 1. 71)

(.34 - 1.88)

(.60 - 1.20)

(.49 - 1.17)

TABLE7

DURATION OF LABOR AND HOSPITALIZATION INTERVENTION AND CONTROL GROUPS

DURATION I c (HOURS) n=357 n=356

LENGTH OF LABOR 3.83 4.8 (median)

LENGTH OF HOSPITALIZATION 25.5 28.5 (median)

SOURCE: SCREENING QUESTIONNAIRE AND WOMEN'S CLINICAL RECORDS

p-Value

<0.05

0.07

TABLES

CONDITIONS OF THE NEWBORN INTERVENTION AND CONTROL GROUPS

NEWBORN'S GROUP TOTAL OR CONDITION I c

APGAR 1) 3.6% 5.3% 4.5% .67 <7 (13/356) (19/354) (321710)

APGAR(5') 2.8% 4.5% 3.7% .61 <7 (2/356) (6/354) (8/710)

FETAL DISTRESS .18% 17% (17.9%) * 1.12 (67/357) (61/356) (128/713)

* MECONIUM 20% 18% (18.9%) 1.12 (71/357) (64/356) (1351713)

RESUSCITATION 22% 24% 23.1% 1.09 (80/356) (86/357) (166/713)

*OR ADJUSTED FOR PREMATIJRE RUPTURE OF MEMBRANES AND CM OF DILATATION

SOURCE: NEWBORN'S CLINICAL RECORD

IC(95%)

(.33 - 1.36)

(.28 - 1.34)

(.75 - 1.67)

(.77 - 1.68)

(.84 - 1.75)

STATE

CONTROL OVER LABOR

TABLE 9

WOMEN'S EMOTIONAL STATE DURING AND ™MEDIATELY AFTER CHILDBIRTH

INTERVENTION AND CONTROL GROUPS

GROUP TOTAL I c

37.6% 28.8% 33.2% (134/356) (102/353) (236/709)

MODERATE AND LITTLE PAIN 29.7% 26.8% 28.4% DURING LABOR (106/356) (96/352) (202/709)

SOURCE: POSTPARTIJM QUESTIONNAIRE

OR IC(95%)

1.42 (1.07 - 2.06)

1.11 (.80 - 1.53)

TABLE 10

FEEDING THE NEWBORN INTERVENTION AND CONTROL GROUPS

FEEDING GROUP TOTAL CHARACTERISTICS I c

BEGINNING OF BREAST- 11% 8% 9.1% FEEDING IN THE FIRST 8 (35/330) (24/315) (59/645) HOURS OF LIFE

EXCLUSIVE BREAST-FEEDING 12% 7% 9.8% * (41/334) (24/320) (65/657)

FULL BREAST-FEEDING 37% 36% 36.7% (125/334) (116/320) (241/657)

BREAST-FEEDING 42% 41% 42% PLUS FORMULA (141/334) (131/320) (272/357)

FEEDING ON 77% ' 79% 78% DEMAND (242/316) (229/289) (471/605)

BEHAVIOR THAT PROMOTES BREAST-FEEDING [BREAST LEFT UNCOVERED 60.9% 24.7% 43% AFrER BREAST-FEEDING (187/309) (74/299) (261/608)

PROPER CARE OF 21% 9.4% 15% NIPPLES (71/334) (30/318) (101/652)

* OR ADJUSTED FOR PREVIOUS BREAST-FEEDING

SOURCE: HOME VISIT QUESTIONNAIRE

OR IC(95%)

1.46 (.82 -2.60)

1.73 (1.01 - 2.88)

1.03 (.76 - 1.40)

1.05 (.76 - 1.46)

.86 (.57 - 1.28)

4.66 (3.29 - 6.60)

2.59 (l.60 - 4.21)

REASONS

TABLE 11

REASONS FOR NOT BREAST-FEEDING OR FOR SUPPLEMENTING WITH A FORMULA

INTERVENTION AND CONTROL GROUPS

GROUP TOTAL I c

BECAUSE THE MILK DRIED UP 17.6% 44% 31.4% (6/34) (16/36) (22/70)

MOTHER'S MEDICAL 44.1% 22.2% 32.8% !PROBLEMS (15/34) (8/36) (23170)

MOTHER'S 14.7% 2.7% 8.5% HOSPITALIZATION (5/34) (1/36) (6170)

ON DOCTOR'S ORDERS 13.90/o 24.2% 19.6% (17/122) (34/140) (511262)

OR IC(95%)

.27 (09 - .79)

2.76 (.99 - 7.65)

6.03 (.80 - 00)

.50 (.27 - .95)

TABLE12

AVERAGE COST PER RELEVANT ACTIVfIY

ACTIVITIES* AVERAGE COST

HOSPITAL DAY (24 HOURS) IN THE GYNECO-

OBSTETRICS UNIT+ $ 873.60

LABORATORY TEST $ 17.00

IX-RAY, ULTRASOUND, OPERATING THEATER COST FOR CESAREAN SECTION $ 1,289.00

* INFORMATION OBTAINED FROM GYNECO-OBSTETRICS HOSPITAL NO. 4 CASTELAZO AYALA

+ THE COST OF THIS SERVICE INCLUDES DIRECT COST (CAPITAL AND EXPENDIBLES) AS

WELL AS INDIRECT SERVICES SUCH AS SOCIAL WORK, CLINICLA RECORDS, PHARMACY, FOOD, MATERNITY WARD, HOSPITAL STRUCTURE, ELECTRICITY, ETC. AND IT'S EXPRESSED IN MEXICAN PESOS.

TABLE 13

COST OF THE DOULA SUPPORT PROGRAM

ACTIVITIES A VERA GE COST

TRAININGPROGRAMFORTHEDOULAS $ 7,040.00

PRINTING BREAST-FEEDING MANUALS AND STATIONERY $ 3,794.00

DOULA'S REMUNERATION $ 145,873.00

HOURLY COST PER DO ULA $ 19.39

AVERAGEHOURSDOULA/MOTHER 5.39 horas

COST OF DOULA PER WOMEN $ 104.51

TABLE 14

COMPARISON OF THE INTERVENTION AND CONTROL GROUPS ACCORDING TO AVERAGE COST

PER WOMAN

CHARACTERISTICS INTERVENTION CONTROL SIGNIFICANCE

HOSPITALIZATION COST $ 930.00 $ 1,041.70 < .05

COST OF MEDICINES $ 31.00 $ 28.00 NS

COST OF LAB TEST $ 15.00 $ 18.00 NS

COST OF SURGICAL ROOM $ 327.00 $ 412.00 NS

COST OF BREAST-FEEDING !PROMOTION PROGRAM $ 2.56 $ 2.12 NS

COST OF DOULA SUPPORT IPR OGRAM $ 104.50 -

TOTAL COST $ 1,054.00 $ 1,104.00 NS

TABLE15

COST-EFFECTIVENESS INDEXES

CRITERIA INTERVENTION CONTROL % INCREASE IN

COSTS IE~~~- COSTS IEF~;~- EFFECTIVENESS

AVERAGE COST PER WOMAN $ 1,054.00 $ 1,104.00 5%

k\ VERA GE LENGTH OF LABOR 3.8 hrs. 4.8 hrs. 26%

(median)

k\ VERA GE LENGTH OF HOSPITALIZATION 25.5 hrs. 28.5 hrs. 12%

(median)

HIGH DEGREE OF CONTROL DURING CHILDBIRTH 38% 28% 49%

EXCLUSIVE BREAST-FEEDING 12% 7% 7% 71%

SOURCE: WOMEN'S RECORDS AND PROJECT QUESTYIONNAIRES

ResearchMonograph 41

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WELLSTART INTERNATIONAL

Wellstart International is a private, nonprofit organiz.ation dedicated to the promotion of healthy families through the global promotion of breastfeeding. With a tradition of building on existing resources, Wellstart works cooperatively with individuals, institutions, and governments to expand and support the expertise necessary for establishing and sustaining optimal infant feeding practices worldwide.

Wellstart has been involved in numerous global breastfeeding initiatives including the Innocenti Declaration, the World Summit for Children, and the Baby-Friendly Hospital Initiative. Programs are carried out both internationally and within the United States.

International Programs Wellstart's Lactation Management Education (LME) Program, funded through USAID/Office of Nutrition, provides comprehensive education, with ongoing material and field support services, to multidisciplinary teams of leading health professionals. With Wellstart' s assistance, an extensive network of Associates from more than 40 countries is in turn providing training and support within their own institutions and regions, as well as developing appropriate in-colllltry model teaching, service, and resource centers.

Wellstart's Expanded Promotion of Breastfeeding (EPB) Program, funded through USAID/Office of Health, broadens the scope of global breastfeeding promotion by working to overcome barriers to breastfeeding at all levels (policy, institutional, community, and individual). Efforts include assistance with national assessments, policy development, social marketing including the development and testing of communication strategies and materials, and community outreach including primary care training and support group development. Additionally, program-supported research expands biomedical, social, and programmatic knowledge about breastfeeding.

National Programs Nineteen multidisciplinary teams from across the U.S. have participated in Wellstart's lactation management education programs designed specifically for the needs of domestic participants. In collaboration with universities across the colllltry, Wellstart has developed and field-tested a comprehensive guide for the integration of lactation management education into schools of medicine, nursing and nutrition. With funding through the MCH Bureau of the U.S. Department of Health and Human Services, the NIH, and other agencies, Wellstart also provides workshops, conferences and consultation on programmatic, policy and clinical issues for healthcare professionals from a variety of settings, e.g. Public Health, WIC, Native American. At the San Diego facility, activities also include clinical and educational services for local families.

Wellstart International is a designated World Health Organization Collaborating Center on Breastfeeding Promotion and Protection, with Particular Emphasis on Lactation Management Education.

For information on corporate matters, the LME or National Programs, contact: Wellstart International Corporate Headquarters tel: (619) 295-5192 4062 First Avenue fax: (619) 294-7787 San Diego, California 92103 USA e-mail: [email protected]

For information about the EPB Program contact: Wellstart International 3333 K Street NW, Suite 101 Washington, DC 20007 USA

tel: (202) 298-7979 fax: (202) 298-7988 e-mail: [email protected]

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