Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Peter Brocklehurst
ORCID ID
Contact details
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
-
peter.brocklehurst@npeu.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0500959/G1000469
Study information
Scientific title
International study of caesarean section surgical techniques: a randomised fractional factorial trial and follow-up study
Acronym
CORONIS
Study hypothesis
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
1. Oxford Tropical Research Ethics Committee (OXTREC), 05/03/2007, ref: 013-06
2. Follow-up study: OXTREC,17/11/2010, ref: 013-06
Study design
Multicentre factorial randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient 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
Condition
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
Phase
Drug names
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 trial start date
01/09/2006
Overall trial end date
30/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
15,729
Participant 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.
Recruitment start date
01/09/2006
Recruitment end date
30/06/2015
Locations
Countries of recruitment
Argentina, Chile, Ghana, India, Kenya, Pakistan, Sudan
Trial participating centre
University of Oxford
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Clinical Trials and Research Governance Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom
-
Heather.House@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (Grant ref: G0500959)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18336721
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23721753
2014 follow-up protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24261693
2016 3-year follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/27155903
Publication citations
-
Protocol
The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial, BMC Pregnancy Childbirth, 2007, 7, 24, doi: 10.1186/1471-2393-7-24.
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Results
Abalos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, Hardy P, Juszczak E, Mathews JE, Masood SN, Oyarzun E, Oyieke J, Sharma JB, Spark P, Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial, Lancet, 2013, 382, 9888, 234-248, doi: 10.1016/S0140-6736(13)60441-9.
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Protocol
Abalos E, Oyarzun E, Addo V, Sharma JB, Matthews J, Oyieke J, Masood SN, El Sheikh MA, Brocklehurst P, Farrell B, Gray S, Hardy P, Jamieson N, Juszczak E, Spark P, CORONIS - International study of caesarean section surgical techniques: the follow-up study, BMC Pregnancy Childbirth, 2013, 13, 215, doi: 10.1186/1471-2393-13-215.
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Results
CORONIS collaborative group, Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial, Lancet, 2016 , doi: 10.1016/S0140-6736(16)00204-X.