Detlefsen 1980.
Methods | RCT. | |
Participants | Setting: Denmark. 117 women with a medio‐lateral episiotomy. This was a subgroup of the main trial. Method of delivery: spontaneous vaginal with cephalic presentation. Parity: primigravida and multigravida included. Mean age: not specified between groups. Operator: doctors and midwives. |
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Interventions | Method of repair: as described below. Women divided into 2 groups. Group 1 (N = 65), vaginal trauma sutured with a continuous locking stitch, perineal muscle and skin sutured using the interrupted technique with Dexon 1/0 on a T‐125 needle. Group 2 (N = 52), vaginal trauma sutured with a continuous locking stitch, perineal muscle closed with a continuous non‐locking (running) stitch and perineal skin closed using an intracutaneous (subcuticular) technique with Dexon 1/0 on a T‐125 needle. | |
Outcomes | Included in analysis:
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Notes | Method of repair: described. Training period: midwives and doctors underwent training for 1 month in the new suturing technique used in group 2. All women delivered between 1 April 1978 and 31 July 1978 with an episiotomy were randomised into the trial. Long‐term follow‐up: 2 and 6 months' postpartum. Does not state if trial had Research Ethics Committee approval. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Allocated by 'randomisation': method not described. |
Allocation concealment (selection bias) | Unclear risk | Allocated by 'randomisation'. No information available regarding concealment of treatment allocation. |
Blinding (performance bias and detection bias) Clinical staff | High risk | Different suture techniques. |
Blinding (performance bias and detection bias) Women | High risk | Not stated but women may have been aware of suturing technique. |
Blinding (performance bias and detection bias) Outcome assessors | High risk | |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not clear and not clear whether analysis was by 'intention to treat'. |
Selective reporting (reporting bias) | Unclear risk | Not apparent. |