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