International study of caesarean section surgical techniques: a randomised fractional factorial trial and follow-up study

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).

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
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).