Methods | Generation method of randomization not established. Concealment of allocation by opaque sealed envelopes. |
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Participants | 1000 women randomized with spontaneous vaginal deliveries, live singleton fetus, at least 37 completed weeks of gestational age, cephalic presentation From the 1000 original women randomized in the original trial, 922 were available for follow up and 674 of them responded to a postal questionnaire which are the women included in the analysis |
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Interventions | “Try to avoid episiotomy”: the intention should be to avoid an episiotomy and performing it only for fetal indications (fetal bradycardia, tachycardia, or meconium stained liquor) “Try to prevent a tear”: the intention being that episiotomy should be used more liberally to prevent tears |
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Outcomes | Severe maternal trauma: extension through the anal sphincter or to the rectal mucosa or to the upper 3rd of the vagina. Apgar score less than 7 at 1 minute. Severe or moderate perineal pain 10 days after delivery. Admission to special care baby unit in first 10 days of life. Perineal discomfort 3 months after delivery. No resumption of sexual intercourse 3 months after delivery Any dyspareunia in 3 years. Any incontinence of urine at 3 years. Urinary incontinence severe to wear a pad at 3 years |
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Notes | Mediolateral episiotomies. Epsiotomy rates were 10.2% for restricted group and 51.4% for the routine group | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A - Adequate |