8/18/2019 NGC-9419

1/5

Guideline Summary NGC-9419

Guideline Title

Management of preterm labor.

Bibliographic Source(s)

American College of Obstetricians and Gynecologists (ACOG). Management of preterm labor. Washington (DC): American College of Obstetricians and Gynecologists (ACOG);

2012 Jun. 10 p. (ACOG practice bulletin; no. 127). [86 references] PubMed 

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: American College of Obstetricians and Gynecologists (ACOG). Management of preterm labor. Washington (DC): American College of 

Obstetricians and Gynecologists (ACOG); 2003 May. 9 p. (ACOG practice bulletin; no. 43). [74 references]

FDA Warning/Regulatory Alert

Note from the National Guideline Clear inghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  July 9, 2015 - Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDS)  : The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning

that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDA’s comprehensive review of new safety

information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of ov er-

the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug

Facts labels.

Scope

Disease/Condition(s)

Preterm labor

Guideline Category

Evaluation

Management

Prevention

Clinical Specialty

Emergency Medicine

Obstetrics and Gynecology

Intended Users

Advanced Practice Nurses

Nurses

Physician Assistants

Physicians

Guideline Objective(s)

To present the various methods proposed to manage preterm labor and to review the evidence for the roles of these methods in clinical practice

Note: Identification and management of risk factors for preterm labor are not addressed in this document.

Target Population

Women in preterm labor

Interventions and Practices Considered

1. Tocolytic therapy, including beta-adrenergic agonists; calcium channel blockers; non-steroidal anti-inflammatory drugs (NSAIDs)

2. Fetal neuroprotection (magnesium sulfate)

3. Antenatal corticosteroids (dexame thasone, betamethasone)

Note: Bed rest and hydration were considered but not routinely recommended. Repeated and maintenance tocolytic therapies and antibiotics to prolong gestation were also

considered, but not recommended as a general practice.

Major O utcomes Considered

  Predictive value of tests for risk of preterm birth

  Neonatal morbidity and mortality

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm454141.htmhttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=22617615

8/18/2019 NGC-9419

2/5

  Maternal and fetal side effects associated with treatment

  Effectiveness of tocolytics and antibiotics in prolonging pregnancy or improving neonatal outcomes

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)

Hand-searches of Published Literature (Secondary Sources)

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

The MEDLINE database, the Cochrane Library, and the American College of Obstetricians and Gynecologists' own internal resources and documents were used to conduct a

literature search to locate relevant articles published between: January 1990 - March 2012. The sea rch was restricted to articles published in the English language. Priority was

given to articles reporting results of original research, although review articles and commentaries also were consulted. Abstracts of research p resented at sympos ia and scientific

conferences were not considered adequate for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of Health and the

American College of Obstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies of identified articles. When reliable research

was not available, expe rt opinions from obstetrician–gynecologists were used.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force.

I Evidence obtained from at least one properly designed randomized controlled trial

II-1 Evidence obtained from well-designed controlled trials without randomization

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled exper iments also could be rega rded as this type of ev idence.

III Opinions of respected authorities, based o n clinical experience, descr iptive studies, or reports of expert committees

Methods Used to Analyze the Evidence

Review of Published Meta-Analyses

Systematic Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Analysis of available evidence was given priority in formulating recommendations. When reliable research was not available, expert opinions from obstetrician-gynecologists were

used. See also the "Rating Scheme for the Strength of Recommendations" field regarding Level C recommendations.

Rating Scheme for the Strength of the Recommendations

Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:

Level A — Recommendations are based on good and consistent scientific evidence.

Level B — Recommendations are based on limited or inconsistent scientific evidence.

Level C — Recommendations are based primarily on consensus and expert opinion.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Internal Peer Review

Description of Method of Guideline Validation

Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologists generalists and sub-specialists. The final guidelines are

also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board.

Recommendations

Major Recommendations

The grades of evidence (I-III) and levels of recommendations (A-C) are defined at the end of the "Major Recommendations" field.

The following recommendations and conclusions are based on good and consistent scientific evidence (Level A):

  A single course of corticosteroids is recommended for pregnant women between 24 weeks of gestation and 34 weeks of ges tation who are at risk of preterm delivery

within 7 day s.

8/18/2019 NGC-9419

3/5

  Accumulated available ev idence suggests that magnesium sulfate reduces the severity and risk of cerebra l palsy in surviving infants if administered when birth is

anticipated before 32 weeks of gestation. Hospitals that elect to use magnesium sulfate for fetal neuroprotection should develop uniform and specific guidelines for their

departments rega rding inclusion criteria, treatment regimens, concurrent tocolysis, and monitoring in accordance with one of the larger trials.

  The evidence supports the use of first-line tocolytic treatment with beta-adrenergic agonist therapy, calcium channel blockers, or non-steroidal anti-inflammatory drugs

(NSAIDs) for short-term prolongation of pregnancy (up to 48 hours) to allow for the adm inistration of antenatal steroids.

  Maintenance therapy with tocolytics is ineffective for preventing preterm birth and improving neonatal outcomes and is not recommended for this purpose.

  Antibiotics should not be used to prolong gestation or improve neonatal outcomes in women with pre-term labor and intact membranes.

The following recommendations and conclusions are base d on limited or inconsistent scientific evidence (Level B):

  A single course of repeat antenatal corticosteroids should be considered in women whose prior course of antenatal corticosteroids was administered at least 7 days

previously and who remain at risk of preterm birth before 34 weeks of gestation.

  Bed rest and hydration have not been shown to be effective for the prevention of preterm birth and should not be routinely recommended.

  The positive predictive value of a positive fetal fibronectin test result or a short cervix alone is poor and should not be used exclusively to direct management in the

setting of acute symptoms.

Definitions:

Grades of Evidence

I Evidence obtained from at least one properly designed randomized controlled trial

II-1 Evidence obtained from well-designed controlled trials without randomization

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled exper iments also could be rega rded as this type of ev idence.

III Opinions of respected authorities, based o n clinical experience, descr iptive studies, or reports of expert committees

Levels of Recommendations

Level A — Recommendations are based on good and consistent scientific evidence.

Level B — Recommendations are based on limited or inconsistent scientific evidence.

Level C — Recommendations are based primarily on consensus and expert opinion.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Safe and effective management of women with preterm labor

Potential Harms

Common Tocolytic Agents

Calcium Channel Blockers

  Maternal side effects: Dizziness, flushing, and hypotension; suppression of heart rate, contractility, and left ventricular systolic pressure when used with magnesium

sulfate; and elevation of hepatic transaminases

  Fetal or newborn adverse effects: No known adverse e ffects

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

  Maternal side effects: Nausea, esophageal reflux, gastritis, and emesis; platelet dysfunction is rarely of clinical significance in patients without underlying bleedingdisorder

  Fetal or newborn adverse effects: In utero constriction of ductus arteriosus*, oligohydramnios*, necrotizing enterocolitis in preterm newborns, and patent ductus

arteriosus in newborn†

*Greatest risk as sociated with use for longer than 48 hours

†Data a re conflicting regarding this ass ociation

Beta-adrenergic Receptor Agonists

  Maternal side effects: Tachycardia, hypotension, tremor, palpitations, shortness of breath, chest discomfort, pulmonary edema, hypokalemia, and hyperglycemia

  Fetal or newborn adverse effects: Fetal tachycardia

Magnesium Sulfate

  Maternal side effects: Causes flushing, diaphoresis, nausea, loss of deep tendon reflexes, respiratory depre ssion, and cardiac arrest; suppresses heart rate, contractility

and left ventricular systolic pressure when used with calcium channel blockers; and produces neuromuscular blockade when used with calcium-channel blockers.

  Fetal or newborn adverse effec ts: Neonatal depression (The use of magnesium sulfate in doses and duration for fetal neuroprotection alone does not appear to beassociated with an increased risk of neonatal depression when correlated with cord blood magnesium levels.)

Contraindications

Contraindications

  Ca lcium channel blockers - Hypotension and preload-dependent cardiac lesions, such as aortic insufficiency

8/18/2019 NGC-9419

4/5

  Non-steroidal Anti-inflammatory Drugs (NSAID s) - Platelet dysfunction or bleeding disorder, hepatic dysfunction, gastrointestinal ulcerative disease, renal dysfunction, and

asthma (in women with hypersensitivity to aspirin)

  Beta-adrenergic receptor agonists - Tachycard ia-sensitive maternal cardiac disease and poorly controlled diabetes mellitus

  Magnesium sulfate - Myasthenia gravis

  Tocolysis

  Intrauterine fetal demise

  Lethal fetal anomaly

  Nonreassuring fetal status

  Severe preeclampsia or eclampsia

  Maternal bleeding with hemodynamic instability

  Chorioamnionitis

  Preterm premature rupture of membranes*

  Maternal contraindications to tocolysis (agent specific)

*In the absence of maternal infection, tocolytics may be considered for the purposes of maternal transport, steroid administration, or both.

Qualifying Statements

Qualifying Statements

These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be warranted based on the needs of the

individual patient, resources, and limitations unique to the institution or type of practice.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Audit Criteria/Indicators

Chart Documentation/Checklists/Forms

Patient Resources

For information about availability, s ee the Availability of Companion Documents and Patient Resources fields bel ow.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Getting Better

Staying Healthy

IOM Domain

Effectiveness

Identifying Information and Availabili ty

Bibliographic Source(s)

American College of Obstetricians and Gynecologists (ACOG). Management of preterm labor. Washington (DC): American College of Obstetricians and Gynecologists (ACOG);

2012 Jun. 10 p. (ACOG practice bulletin; no. 127). [86 references] PubMed 

Adaptation

Not applicable: The guideline was not adapted from another source .

Date Released

2003 May (revised 2012 Jun)

Guideline Developer(s)

American College of Obstetricians and Gynecologists - Medical Specialty Society

Source(s) of Funding

American College of Obstetricians and Gynecologists (ACOG)

Guideline Committee

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins — Obstetrics

Composition of Group That Authored the Guideline

American College of Obstetricians and Gynecologists (ACOG) committees are created or abolished and their overall function defined by the Executive Board. Appointments are

made for o ne year, with the understanding that such appointment may be continued for a total of three years. The ma jority of committee members are Fellows, but Junior Fellows

also are e ligible for appointment. Some committees may have repr esentatives from other organizations when this is particularly appropriate to committee activities. The

president elect appoints committee members annually.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=22617615

8/18/2019 NGC-9419

5/5

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: American College of Obstetricians and Gynecologists (ACOG). Management of preterm labor. Washington (DC): American College of 

Obstetricians and Gynecologists (ACOG); 2003 May. 9 p. (ACOG practice bulletin; no. 43). [74 references]

Guideline Availability

Electronic copies: None available

Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 933104, Atlanta, GA 31193-3104;

telephone, 800-762-2264, ext. 192; e-ma il: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site  .

Availability of Companion Documents

The following is available:

  Magnesium sulfate before anticipated preterm birth for neuroprotection. Patient safety checklist. Atlanta (GA): American College of Obstetricians and Gynecologists

(ACOG); 2012 Aug. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the American College of Obstetricians and Gynecologists (ACOG) Web site  

.

In addition, a proposed per formance me asure is included in the original guideline document.

Patient Resources

The following is available:

  Frequently asked questions: Preterm Labor Atlanta (GA): American C ollege of Obstetricians and Gynecologists (ACOG); 2011 May. 3 p. Electronic copies: Available in

Portable Document Format (PDF) from the American College of Obstetricians and Gynecologists (ACOG) Web site   .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their

diagnos ed diso rders. By providing access to this p atient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients

and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis

and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the

authors or publishers of tha t original guideline. The patient information is no t reviewed by NGC to es tablish whether or not it accurately reflects the original guideline's content.

NGC Status

This summary was completed by ECRI on February 4, 2004. The information was verified by the guideline developer on July 26, 2004. The information was reaffirmed by the

guideline developer in 2008 and updated by ECRI Institute on February 9, 2010. This summary was updated by ECRI Institute on March 11, 2011 following the U.S. Food and

Drug Administration (FDA) adv isory on Terbutaline. This NGC summary was updated by ECRI Institute on January 21, 2013. This summary was updated by EC RI Institute on July

12, 2013 following the U.S. Food and Drug Administration advisory on Magnesium Sulfate. This summary was updated by ECRI Institute on September 18, 2015 following the U.S.

Food and Drug Administration advisory on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private

organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may

be found at http://www.guideline.gov/about/inclusion-criteria.aspx .

NGC, AHRQ, and its contractor ECRI I nstitute make no warr anties concerning the content or clinical efficacy or e ffectiveness of the clinical practice guidelines and related

materials represented on this site. Moreover, the views and opinions of developer s or authors of guidelines repre sented on this site do not necessa rily state or reflect those of 

NGC, AHRQ, or its contractor ECRI I nstitute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Reader s with questions regarding guideline content are directed to contact the guideline developer.

http://localhost/var/www/apps/conversion/tmp/scratch_7/about/inclusion-criteria.aspxhttp://www.acog.org/~/media/For%20Patients/faq087.pdf?dmc=1&ts=20130121T1139286717http://www.acog.org/~/media/Patient%20Safety%20Checklists/psc007.pdf?dmc=1&ts=20130121T1200237626http://sales.acog.org/mailto:sales@acog.org