1. International study of caesarean section 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. Each woman is allocated to a combination of three of the five interventions 1.Blunt versus sharp abdominal entry 2.Exteriorisation of the uterus for repair versus intra- abdominal repair 3.Single versus double layer closure of the uterus 4.Closure versus non-closure of the peritoneum (pelvic and parietal) 5.Chromic catgut versus Polyglactin-910 for uterine repair Interventions

5. 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

6. 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

7. Women recruited worldwide15,936 Trial Entries logged at RTOs15,894 (99.7%) Complete data collection booklets 15,894 (99.7%) Complete 6 week forms15,482 (97.1%) Data received in Oxford

8. Argentina 1,639 Chile 1,231 Ghana1,279 India: Delhi3,833 Vellore2,111 Kenya1,684 Pakistan2,554 Sudan1,606

9. 15,936 women recruited 2007-2010

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

11. 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

12. THE FOLLOW-UP STUDY at 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. Recruitment, continued contact and FU assessment of women at least 3 years after trial entry 200720082009201020112012201320142015 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

19. 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

21. 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 for Completing 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

22. 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 YES Complete 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

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