International study of caesarean section surgical techniques: a randomised fractional factorial trial and follow-up study
| ISRCTN | ISRCTN31089967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31089967 |
| Secondary identifying numbers | G0500959/G1000469 |
- Submission date
- 29/11/2006
- Registration date
- 17/01/2007
- Last edited
- 10/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Brocklehurst
Scientific
Scientific
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
| peter.brocklehurst@npeu.ox.ac.uk |
Study information
| Study design | Multicentre factorial randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Information leaflet in English for main trial http://www.npeu.ox.ac.uk/downloads/coronis/CORONIS-Information-for-Women.pdf and for the follow-up study https://www.npeu.ox.ac.uk/files/downloads/coronis-follow-up/Information-for-women-V1-June-2011.pdf |
| Scientific title | International study of caesarean section surgical techniques: a randomised fractional factorial trial and follow-up study |
| Study acronym | CORONIS |
| Study objectives | Study hypothesis amended as of 02/08/2007: The CORONIS Trial aims to evaluate alternative surgical techniques for five specific aspects of caesarean section technique in a large pragmatic randomised controlled trial, to help determine which methods lead to an optimum outcome for women and their infants. During the trial development phase it was known as the International CAESAR study. |
| Ethics approval(s) | 1. Oxford Tropical Research Ethics Committee (OXTREC), 05/03/2007, ref: 013-06 2. Follow-up study: OXTREC,17/11/2010, ref: 013-06 |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth |
| Intervention | There are five pairs of interventions being tested; however, each participating hospital will only take part in three of these five possible comparisons. The interventions being compared are: 1. Blunt versus sharp abdominal entry 2. Exteriorisation of the uterus 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 Vicryl for uterine closure |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current information as of 29/09/10: Death or maternal infectious morbidity (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 of >1 unit of whole blood or packed cells. Initial information at time of registration: Death or serious maternal morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis or wound infection; further operative procedures on the wound; blood transfusion). |
| Secondary outcome measures | All within six weeks of delivery unless stated otherwise: 1. Death 2. Febrile morbidity 3. Endometritis 4. Wound infection treated with antibiotics 5. Operative procedures on wound 6. Pain 7. Blood transfusion 8. Interventions used for severe primary Post-Partum Haemorrhage (PPH) 9. Stillbirth after trial entry 10. Apgar score less than three at five minutes 11. Laceration of baby at time of caesarean section 12. Death of the baby by six weeks of age 13. Other severe maternal morbidity Health service utilisation: 1. Duration of operation (from incision to closure) 2. Duration of hospital stay post-caesarean section 3. Duration of stay in Intensive Care Unit post-caesarean section 4. Number and duration of re-admissions to hospital within six weeks of the caesarean section Added as of 13/03/2013: Follow-up Study Outcomes Womens health and mortality 1. Following the CORONIS birth and before any subsequent pregnancy, any new onset or worsening of: 1.1. pelvic pain 1.2. dysmenorrhoea 1.3. deep dyspareunia 1.4. urinary symptoms of poor stream and/or frequency which did not respond to antibiotics 2. Diagnostic laparoscopy or diagnostic laparotomy (not related to pregnancy) 3. Hysterectomy or tubal/ovarian surgery (not related to pregnancy) 4. Bladder or bowel damage in those women who have had surgery, excluding diagnostic laparoscopy and diagnostic laparotomy (not related to pregnancy). 5. Following the CORONIS birth, any new onset of: 5.1. abdominal hernia 5.2. bowel obstruction 6. Womans death Reproductive status 7. Number of women with no subsequent pregnancy 7.1. Voluntary infertility 7.2. Involuntary infertility 8. Use of fertility treatments Subsequent pregnancies 9. Number of women having any subsequent pregnancy and for these women, the following outcomes will be measured: 9.1. Inter-pregnancy interval from the CORONIS birth to the end of the subsequent pregnancy (regardless of loss or birth) 9.2. Miscarriage of the pregnancy subsequent to the CORONIS birth 9.3. Ectopic pregnancy 9.4. Gestation at delivery (by best estimate) of the first viable pregnancy (gestational age > 24 or >28 weeks depending on country specific definition) 9.5. Stillbirth 9.6. Neonatal death 9.7. Mode of delivery: 9.7.1. Non-instrumental vaginal 9.7.2. Instrumental vaginal 9.7.3. Pre-labour caesarean section 9.7.4. In labour caesarean section 9.8. Other pregnancy complications including: uterine rupture, uterine scar dehiscence, placenta praevia, morbidly adherent placenta, abruption, postpartum haemorrhage requiring transfusion, severe infection within 6 weeks postpartum, hysterectomy up to 6 weeks postpartum, manual removal of placenta, 9.9. Bladder or bowel damage at the time of subsequent caesarean section CORONIS children morbidity and mortality 10. Death or serious morbidity of the child who was born at the time of CORONIS participation (Although no difference in death is expected, there is likely to be a time difference between sharp and blunt abdominal entry and this may, in theory, lead to more neonatal encephalopathy which may lead to a greater risk of later death). |
| Overall study start date | 01/09/2006 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 15,729 |
| Key inclusion criteria | Women will be eligible for trial entry if they are undergoing delivery by lower segment caesarean section through a transverse abdominal incision. Note: women are eligible if they have had no previous, or one previous, caesarean section. Fever in labour is not a contra-indication to trial entry. Added as of 13/03/2013: All women recruited into the CORONIS Trial and eligible for three year follow-up will have a health assessment conducted by a study assessment doctor. |
| Key exclusion criteria | Women will not be eligible for trial entry if there is clear indication for a particular surgical technique or material to be used, that interferes with any of the allocated interventions, e.g. in a previous vertical incision. |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Argentina
- Chile
- England
- Ghana
- India
- Kenya
- Pakistan
- Sudan
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials and Research Governance Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
| Heather.House@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research council
Medical Research Council (UK) (Grant ref: G0500959)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/10/2007 | Yes | No | |
| Results article | results | 20/07/2013 | Yes | No | |
| Protocol article | follow-up protocol | 21/11/2013 | Yes | No | |
| Results article | 3-year follow-up results | 02/07/2016 | Yes | No |
Editorial Notes
10/05/2016: Publication reference added.
13/03/2013: the following changes were made to the trial record, in order to include details of the follow-up study:
1. The public title was previously "International study of caesarean section surgical techniques: a randomised factorial trial".
2. The overall trial end date was changed from 30/09/2011 to 30/06/2015.
3. The target number of participants was updated from 15,000 to 15,729.
