International study of caesarean section surgical techniques

1. International study of caesareansection surgical techniques THE FOLLOW-UP STUDY

2. The CORONIS Trial Follow-up Study is funded by the UK Medical Research Council

3. 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

4. Interventions Each woman is allocated to a combination of three of the five interventions Blunt versus sharp abdominal entry Exteriorisation of the uterus for repair versus intra-abdominal repair Single versus double layer closure of the uterus Closure versus non-closure of the peritoneum (pelvic and parietal) Chromic catgut versus Polyglactin-910 for uterine repair

5. Primary outcome Composite outcome of: Death ormaternal 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)

6. Data collection 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

7. 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

8. Argentina 1,639 Chile 1,231 Ghana 1,279 India: Delhi 3,833 Vellore 2,111 Kenya 1,684 Pakistan 2,554 Sudan 1,606

9. 15,936 women recruited2007-2010

10. Participating countries • Argentina • Chile • Ghana • India: two regions; Delhi and Vellore • Kenya • Pakistan • Sudan • 19 participating hospitals

11. Investigator Group • Chief InvestigatorProfessor 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

12. THE FOLLOW-UP STUDYat least three years after having a caesarean section in the CORONIS Trial

13. 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.

14. 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

15. 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

16. 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

17. The Study Team • Each Regional Trial Office will have a: • Study Co-ordinator • Data Manager • Follow-up Assistant • Data Assistant • Dedicated assessment doctor(s)

18. Timeline and workload

19. 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 Follow-up health assessments

21. Follow-up Procedures Use contact database for woman’s details Use Assessment Due report and Call Back report Plan for - Clinic space - Doctors availability - What to do if unable to contact woman, or ‘other contact’ given Use Appointment Form and call woman to make assessment appointment Log appointment on database using Appointment Form • If woman pregnant, make appointment after delivery • - Log EDD on database Use Appointments Report produced by computer Plan for - Accessing notes in different hospitals - Requesting notes (build in retrieval time) - Paying for notes? 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 Doctors to complete appointment list by marking as ‘attended’ and ‘did not attend’ Give hospital notes, if available, appointment list, HAQs, spare forms and Event Forms to Doctors No show (DNA) Complete HAQ Plan for Completing Event Forms in batches according to treating hospital If yes, Event Form must be completed Is there an Event on the HAQ? NO Return HAQ to Regional Trial Office

22. ASSESSMENT PROCEDURES The CLINIC BOX should contain all necessary documents and a list of women attending for assessment Give the woman and Information for Women sheet or explain the purpose of the study to her Give the woman a Consent Form to sign. Read a Consent Form to the woman if necessary Witness and date the Consent Form NB: A signed consent Form is only required if it necessary to comply with your local Ethics Committee approval Take a full medical history from the woman using the Health Assessment Questionnaire (HAQ) as your guide Is there an Event reported on HAQ? Check that all questions on the HAQ have been covered in the interview Check that all relevant questions have been answered Sign and date the questionnaire YES NO Do you have the hospital records? 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 Complete clinic list and send all completed HAQs, Pregnancy Sections and Event Forms (if applicable) to the Regional Trial Office Complete an Event Report Form YES

23. Shan Rich Study Co-ordinator Patsy Spark IT Co-ordinator Barbara Farrell Trial Director Thank you