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

Morano 2006.

Methods RCT.
Participants Setting: single centre (University Hospital, Italy).
214 women with a second‐degree tear or episiotomy. 
 Method of delivery: spontaneous vaginal deliveries after 37 weeks' gestation. 
 Parity: primiparous. 
 Mean age: continuous (group A) = 28 years; interrupted (group B) = 27 years. 
 Operators: young medical doctors with supervision provided by an experienced doctor.
Interventions Method of repair: as described below. 
 Women divided into 2 groups. 
 Group A (N = 107), vaginal trauma, perineal muscles and skin repaired with loose, continuous non‐locking technique. Suture material rapidly absorbed polyglactin 910 (Vicryl Rapide) ‐ gauge 0 for vagina, perineal muscles and skin. Needle size not specified. 
 Group B (N = 107) vaginal trauma repaired with a continuous non‐locking stitch; perineal muscle and skin sutured with interrupted method. Suture material: rapidly absorbed polyglactin 910 (Vicryl Rapide) ‐ gauge 0 for vagina, 1 for perineal muscles and 2/0 for skin. Needle size not specified.
Outcomes Included in analysis:

  • short‐term pain at 48 hours and 10 days;

  • suture removal, wound dehiscence at 10 days;

  • oral analgesia at 48 hours;

  • dyspareunia at 3 months.
Notes Method of repair: method described. 
 Training period: doctors had opportunity to practice 2 methods prior to commencement of study. 
 Local research ethics committee approval obtained.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Computer‐generated list of random numbers.
Allocation concealment (selection bias) Low risk Sealed and consecutively numbered opaque envelopes (instructions for method of repair written on cards within envelopes).
Blinding (performance bias and detection bias) 
 Clinical staff High risk Different suture techniques.
Blinding (performance bias and detection bias) 
 Women Unclear risk Stated that trial was double blind, but women may have been aware of sutures.
Blinding (performance bias and detection bias) 
 Outcome assessors High risk It would be difficult to blind the assessment of wound healing due to obvious differences in suturing techniques.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 214 women randomised, 19 lost to follow‐up by day 10.
Other bias Unclear risk No baseline imbalance apparent.