Mahomed 1989.
Methods | RCT. Modified factorial ‐ 2 x 3 x 2 design. | |
Participants | Setting: Southmead Hospital, Bristol. 1057 women needing perineal repair following delivery (all tears and episiotomies included). This was a subgroup of the main trial. Method of delivery: spontaneous or instrumental vaginal deliveries. Parity: primigravidae and multiparae. Mean age: group 1 = 26.0 years; group 2 = 25.9 years. Operators: midwives, senior house officers, registrars, consultants, medical students. |
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Interventions | Method of repair: described as below. Women divided into 2 groups. Group 1 (N = 524) vaginal trauma repaired with a continuous stitch, perineal muscle and skin sutured using the interrupted technique. 50% were repaired with Dexon (plus) 2/0 on a multipurpose needle and 50% were repaired with chromic catgut on a 35‐mm tapercut needle. Group 2 (N = 533) vaginal trauma repaired with a continuous stitch, perineal muscle apposed with interrupted stitches and skin sutured using the continuous subcuticular technique. 50% were repaired with Dexon (plus) 2/0 on a multipurpose needle and 50% were repaired with chromic catgut on a 35‐mm tapercut needle. | |
Outcomes | Included in analysis:
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Notes | Method of repair: method described. Subcuticular technique was unpopular with some operators. Training period: not described. No interim analysis. Ethics Committee Approval. Pre‐set trial size had 80% chance of detecting significant clinical differences. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not clear. |
Allocation concealment (selection bias) | Low risk | Serially numbered, sealed opaque envelopes (envelopes contained suture material and instructions for method of repair). 22 envelopes were unaccounted for. |
Blinding (performance bias and detection bias) Clinical staff | High risk | Differences in suture materials and techniques. |
Blinding (performance bias and detection bias) Women | High risk | Women may have been aware of suturing technique. |
Blinding (performance bias and detection bias) Outcome assessors | High risk | Fully blind assessment was not possible owing to obvious differences in suture materials and techniques. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 1574 women randomised. 97% response rate at day 2, 86% at day 10 and 87% at 3 months (1366 women). |
Other bias | Unclear risk | There were some protocol deviations; of those allocated to continuous sutures 18% had interrupted, only 2% of those allocated to interrupted had continuous sutures. "some midwives preferred the interrupted technique... sometimes a midwife called a senior house officer if the allocation was to subcuticular suturing". |