International study of caesarean section surgical techniques
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Transcript of International study of caesarean section surgical techniques
International study of caesareansection surgical techniques
THE FOLLOW-UP STUDY
The CORONIS Trial Follow-up Study is funded by the
UK Medical Research Council
Study design
– CORONIS is a multicentre, fractional factorial randomised controlled trial
– The collaborating institutions are centres with experience in conducting trials
– These centres also have experience in detailed follow-up of large numbers of women
Each woman is allocated to a combination of three of the five interventions
1. Blunt versus sharp abdominal entry2. Exteriorisation of the uterus for repair versus intra-
abdominal repair3. Single versus double layer closure of the uterus4. Closure versus non-closure of the peritoneum (pelvic
and parietal)5. Chromic catgut versus Polyglactin-910 for uterine
repair
Interventions
Composite outcome of:
Death or maternal infectious morbidity
i.e. one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis
or further operative procedures or blood transfusion (>I unit of whole blood/packed cells)
Primary outcome
Data collected:
• At trial entry• Immediately following delivery• Immediately following surgery• During the postpartum stay in hospital• At 6 weeks after discharge from hospital• 3 or 6 monthly thereafter
Data collection
Women recruited worldwide 15,936Trial Entries logged at RTOs 15,894 (99.7%)Complete data collection booklets 15,894 (99.7%)Complete 6 week forms 15,482 (97.1%)
Data received in Oxford
Argentina 1,639 Chile 1,231Ghana 1,279India: Delhi 3,833 Vellore 2,111Kenya 1,684Pakistan 2,554Sudan 1,606
15,936 women recruited2007-2010
• Argentina• Chile• Ghana• India: two regions; Delhi and Vellore• Kenya• Pakistan• Sudan• 19 participating hospitals
Participating countries
Chief Investigator Professor Peter Brocklehurst
Principal Investigators
Argentina Dr Edgardo Abalos
Chile Dr Enrique Oyarzun
Ghana Dr Victor Addo
India: Delhi Dr Jai Sharma
India: Vellore Dr Jiji Mathews
Kenya Professor James Oyieke
Pakistan Dr Shabeen Mazood
Sudan Professor Mohamed ElShiekh
Investigator Group
THE FOLLOW-UP STUDY
at least three years after having a caesarean section in the CORONIS Trial
Two studies of long-term follow-up
1. Single vs double layer uterine closure – 145 women out of 906 randomised – followed up at time of next pregnancy – no difference found between the groups (not surprisingly)
Chapman SJ, Owen J, Hauth JC. One versus two-layer closure of a low transverse cesarean: the next pregnancy. Obstet Gynecol 1997; 89: 16-18.
2. Non-closure vs closure of peritoneum – 144 women out of 280 randomised – no differences found between the groups
Bahmanyar E, Boulvain M, Irion O. Non-closure of the peritoneum during cesarean section: long-term follow-up of a randomized controlled trial. Am J Obstet Gynecol 2001; 185: S125.
Why are we doing the Follow-up Study?
• Lack of evidence of long-term outcomes for women and their families• Unique opportunity to evaluate women following a caesarean section • Biggest cohort• Reassurance for women• Inform clinicians and policy makers
What are we looking for?
Undesirable outcomes for the woman and/or her child
• Problems with fertility
• Problems with obstetric health
• Problems in subsequent pregnancies
• Child’s health
How will the follow-up be done?• The follow-up study will be co-ordinated by the
Regional Trial Office team
• The team will organise appointments with all
women recruited to the CORONIS Trial
• The follow-up interview will take place at least
three years after the woman joined the trial
The Study TeamEach Regional Trial Office will have a:
• Study Co-ordinator
• Data Manager
• Follow-up Assistant
• Data Assistant
• Dedicated assessment doctor(s)
Recruitment, continued contact and FU assessment of women at least 3 years after trial entry
2007 2008 2009 2010 2011 2012 2013 2014 2015
Recruitment Recruitment ended 31/12/10
Continued contact with women Numbers decreasing over time
Follow-up assessments Start 1/9/11
Data analysis and reporting
Timeline and workload
Follow-up health assessments
• Face-to-face interview with a dedicated assessment doctor
• Doctor will take a medical history, guided by the data required to complete the Health Assessment Questionnaire
Use contact database for woman’s details
Use Assessment Due report and Call Back report
If woman has returned to your hospital request hospital notes
Use computer report to complete front page of HAQ and Study Number on each
section for women due to attend
Complete HAQ
Is there an Event on the HAQ?
Return HAQ to Regional Trial Office
Plan for- Clinic space- Doctors availability- What to do if unable to contact woman, or ‘other contact’ given
Plan for- Accessing notes in different hospitals- Requesting notes (build in retrieval time)- Paying for notes?
Doctors to complete appointment list by marking as ‘attended’ and ‘did not attend’
Plan forCompleting Event Forms in batches according to treating hospital
Use Appointments Report produced by computer
NO
Give hospital notes, if available, appointment list, HAQs, spare
forms and Event Forms to Doctors
If yes, Event Form must be
completed
-If woman pregnant, make appointment after delivery
-- Log EDD on database
Use Appointment Form and call woman to make
assessment appointment
Log appointment on database using Appointment Form
No show (DNA)
Follow-up Procedures
Check that all questions on the HAQ have been covered in the
interview
NB: A signed consent Form is only required if it necessary to comply with your local Ethics
Committee approval
Give the woman and Information for Women sheet or explain the
purpose of the study to her
Take a full medical history from the woman using the Health
Assessment Questionnaire (HAQ) as your guide
Do you have the hospital records?
Is there an Event reported on HAQ?
Check that all relevant questions have been answered
Sign and date the questionnaire
YES
Give the woman a Consent Form to sign.
Read a Consent Form to the woman if necessary
Witness and date the Consent Form
YESComplete an Event Report
Form
The CLINIC BOX should contain all necessary
documents and a list of women attending for
assessment
NO
Complete clinic list and send all completed HAQs, Pregnancy Sections and Event Forms (if
applicable) to the Regional Trial Office
If an event form cannot be completed at Assessment the
completed HAQ should be returned to the RTO immediately – the Event Form can be completed when notes
have been located
ASSESSMENT PROCEDURES
Shan Rich Study Co-ordinatorPatsy Spark IT Co-ordinatorBarbara Farrell Trial Director
Thank you