Pregnancy and Childbirth Pregnancy and Childbirth Caesarean section techniques
Conditions
Interventions
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
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Women?s 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. Woman?s 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 | — |
Countries
Argentina, Chile, Ghana, India, Kenya, Pakistan, Sudan
Outcome results
None listed