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. 2010 Jun 16;2010(6):CD000006. doi: 10.1002/14651858.CD000006.pub2

Gemynthe 1996.

Methods RCT.
Participants Setting ‐ Obstetric Unit, Rigshospitalet, Copenhagen, Denmark.
308 women recruited. 
 Inclusion criteria ‐ Danish speaking women with a spontaneous perineal tear or episiotomy requiring suturing. 
 Exclusion criteria ‐ not documented.
Parity ‐ primigravida.
Mean age ‐ not documented. 
 Operator ‐ not documented.
Interventions Method of repair ‐ not described (stated that a continuous subcuticular suture is used in practically all departments of obstetrics in Denmark).
Intervention group (n = 155) ‐ fast‐absorbing polyglactin 910 suture material (Vicryl Rapide) (suture material gauge and size of needle not documented). 
 Comparison group (n = 153) ‐ standard polyglactin 910 suture material (Vicryl) (suture material gauge and size of needle not documented).
Outcomes Pain or discomfort when sitting, lying, walking and defecation at 2 days, 5 days, 2 weeks and 3 months. 
 Insufficient healing, visible sutures and sutures removed up to 8 weeks' postpartum healing.
Time of resumption of intercourse ‐ up to 3 months.
Dyspareunia at 3 months postpartum.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Block randomisation ‐ block size not specified (stratification of randomisation by episiotomy or laceration).
Allocation concealment? Unclear risk States 'two sets of sealed envelopes'.
Blinding? 
 Women Low risk States mothers were not aware of which suture material was used.
Blinding? 
 Clinical staff High risk Obvious differences in colour of suture material and packaging (standard Vicryl is usually dyed purple and Vicryl Rapide is usually undyed).
Blinding? 
 Outcome assessors Unclear risk States project midwives were not aware of which suture material was used (this may be possible in subcutaneous stitches were used). The woman's GP performed the check‐up at 2 months postpartum and was 'unaware of the suture material used'.
Incomplete outcome data addressed? 
 All outcomes Unclear risk Some missing data at all data collection points (pain data 2.9% missing at 48 hrs. 11.7% at 2 weeks and 24% at 3 months).
Free of other bias? Low risk No other bias apparent.