Zafar 2008.
| Methods | RCT, 2‐arm trial (individual randomisation). | |
| Participants | Setting: hospital in Islamabad, Pakistan (the hospital was described as having a high episiotomy rate). Data collection 2002 to 2006. 150 women requiring perineal repair following a mediolateral episiotomy after a spontaneous vaginal delivery. Women who had assisted deliveries or perineal tears were excluded. Parity: both primi‐ and multiparous women included. Mean age: group 1 = 27.2 years; group 2 = 27.2 years. All repairs were carried out by the same surgeon. |
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| Interventions | Group 1: continuous (all layers and skin) with single knot at the apex of the vaginal mucosa. Continuous running stitch to vaginal wall, and muscles sutured in 2 layers, subcuticular sutures to skin, the repair is finished with the needle passing through the muscles lateral to the episiotomy and 4 to 5 cm of suture material is left to hang without a knot. Group 2: 3‐layer technique with continuous stitch to vaginal mucosa, interrupted sutures in 2 layers and continuous (subcuticular) sutures to the skin. Both groups: the repairs were mainly carried out with polyglactin 910 2/0 although 16 had chromic catgut 2/0 sutures (9 versus 7 cases in the 2 groups). |
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| Outcomes | Included in analysis:
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated numbers. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding (performance bias and detection bias) Clinical staff | High risk | Same operator for both study groups. |
| Blinding (performance bias and detection bias) Women | Unclear risk | Not discussed. |
| Blinding (performance bias and detection bias) Outcome assessors | High risk | Outcome assessors would be aware of the type of repair. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 150 women were randomised (it was not clear how many in each group). Full data for only 1 outcome (time taken to carry out the repair) with 29% attrition by day 7 (110/150 available at follow‐up). |
| Selective reporting (reporting bias) | Unclear risk | Not apparent. |
| Other bias | Unclear risk | High attrition and not clear how many randomised to each group. |
ITT: intention to treat PPH: postpartum haemorrhage RCT: randomised controlled trial VAS: visual analogue scale