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. 2012 Nov 14;2012(11):CD000947. doi: 10.1002/14651858.CD000947.pub3

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.
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:
  • dyspareunia at 2 months;

  • not included in analysis owing to data being presented in unsuitable format;

  • short‐term pain at day 5;

  • analgesia at day 5.

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.