Background
Summary of existing evidence
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operative time and length of postoperative stay
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use of extra haemostatic sutures
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defects in the uterine scar or thickness of the uterine scar
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infection or complications of the wound
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postpartum endometritis
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decrease in postoperative haematocrit
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use of blood transfusion
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fever or postoperative febrile morbidity
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pain
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neonatal death
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birth trauma
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admission to neonatal unit
The CORONIS Trial (https://www.npeu.ox.ac.uk/coronis)
Trial eligibility
Trial primary outcome
Trial interventions
Factorial trials
Fractional factorial trials
Methods/Design
The CORONIS Follow-up study
Objective
Hypothesis
Tracing women
Outcomes
Women’s health and mortality
Reproductive status
Subsequent pregnancies
CORONIS children – morbidity and mortality
Outcome reference number | Outcome | Bl vs. Sh | Ext vs.-A | Sl vs. Dble | Cl vs. N-Cl | Cat vs. P910 |
---|---|---|---|---|---|---|
Women’s health and mortality
| ||||||
1 i) | Pelvic pain | s | s | s |
M
| s |
ii) | Dysmenorrhoea | s | s | s | s | s |
iii) | Deep dyspareunia | s | s | s |
M
| s |
iv) | Urinary symptoms | s | s | s | s | s |
2 | Diagnostic laparoscopy or diagnostic laparotomy - not related to pregnancy | s | s | s |
M
| s |
3 | Hysterectomy or tubal/ovarian surgery - not related to pregnancy | s | s | s |
M
| s |
4 | Bladder or bowel damage – not related to pregnancy | s | s | s |
M
| s |
5 i) | Abdominal hernias |
M
| s | |||
ii) | Bowel obstruction | s | s | s |
M
| s |
6 | Woman’s death | s |
M
| s |
M
| |
Reproductive status
| ||||||
7 i) | Women with no subsequent pregnancy – voluntary | s | s | |||
ii) | Women with no subsequent pregnancy – involuntary | s |
M
| s |
M
| s |
8 | Fertility treatments | s |
M
| s |
M
| s |
Subsequent pregnancies
| ||||||
9 | Any subsequent pregnancy | s | s | s | s | s |
i) | Interpregnancy interval | s | s | s | s | s |
ii) | Miscarriage | s | s | s | ||
iii) | Ectopic pregnancy |
M
| s |
M
| s | |
iv) | Gestation | s | s | s | ||
v) | Stillbirth | s |
M
|
M
| ||
vi) | Neonatal death | s |
M
|
M
| ||
vii) | Mode of delivery | s |
M
|
M
| ||
viii) | Other pregnancy complications (composite of a-i) | s |
M
|
M
| ||
a | Uterine rupture | s |
M
|
M
| ||
b | Uterine scar dehiscence | s |
M
|
M
| ||
c | Placenta praevia | s |
M
|
M
| ||
d | Morbidly adherent placenta | s |
M
|
M
| ||
e | Abruption | s |
M
|
M
| ||
f | Postpartum haemorrhage requiring transfusion of >1 unit of whole blood or packed cells | s |
M
|
M
| ||
g | Severe infection within 6 weeks postpartum | s |
M
|
M
| ||
h | Hysterectomy up to 6 weeks postpartum | s |
M
|
M
| ||
i | Manual removal of placenta | s |
M
|
M
| ||
ix) | Bladder or bowel damage –at the time of subsequent Caesarean section | s | s | s | s | s |
CORONIS children – morbidity and mortality
| ||||||
10 | Death or serious morbidity of CORONIS child |
M
|
Data collection
Analysis
Analysis populations
Descriptive analyses
Primary comparative analyses
Sample size and power
Outcome examples | Event rate in 1st group e.g. single layer closure | Event rate in 2nd group e.g. double layer closure | Absolute risk difference | Power available to detect this difference |
---|---|---|---|---|
For all women (number estimated to be ~7,400)
| ||||
Involuntary infertility | 3% | 4.5% | 1.5% | 92% |
Subsequent pregnancy | 48% | 44% | 4% | 93% |
Dyspareunia | 19% | 16% | 3% | 92% |
For women who have a subsequent pregnancy (number estimated to be ~5,900)
| ||||
Uterine rupture or dehiscence | 4% | 5.9% | 1.9% | 92% |
Preterm birth | 10% | 7.5% | 2.5% | 93% |
Discussion
Publication and dissemination of results
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Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data.
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Drafting the article or revising it critically for important intellectual content
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Final approval of the version to be published.