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

Dencker 2006.

Methods RCT.
Participants Setting ‐ Department of Normal Obstetrics/Ostra, Sahlgrenska University Hospital, Gothenburg, Sweden.
1139 women 'randomly allocated'. 
 Inclusion criteria ‐ women having a vaginal delivery with laceration or episiotomy that required suturing by a midwife; singleton pregnancy; cephalic presentation and gestation between 34 and 42 weeks. 
 Exclusion criteria ‐ not documented.
Parity ‐ primigravida and multigravida.
Mean age ‐ not documented. 
 Operator ‐ midwives.
Interventions Method of repair ‐ both continuous and interrupted suturing techniques were used ‐ each midwife used the suturing technique she preferred.
Intervention group (n = 554) ‐ monofilament glycomer 631 (Biosyn) (suture material gauge and size of needle not documented). 
 Comparison group (n = 585) ‐ multifilament polyglycolic acid (Dexon II) (suture material gauge and size of needle not documented).
Outcomes INCLUDED IN ANALYSIS 
 Short‐term pain ‐ up to day 3 (data not presented in paper). 
 Wound healing ‐ up to day 3 (data not presented in paper).
Perineal discomfort/pain ‐ 8 ‐12 weeks postpartum. 
 Wound healing ‐ 8 ‐12 weeks postpartum.
Re‐suturing ‐ up to six months postpartum.
Notes The authors of this study provided additional unpublished data on outcomes.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk 'Random number generator.'
Allocation concealment? Low risk Opaque, sealed, serially numbered envelopes.
Blinding? 
 Women Unclear risk No details given.
Blinding? 
 Clinical staff High risk Difference in suture materials.
Blinding? 
 Outcome assessors High risk Difference in suture materials.
Incomplete outcome data addressed? 
 All outcomes Unclear risk Drop‐out n = 64 (48 envelopes 'discarded' plus 16 questionnaires were missing substantial data). 93% followed up at 1 ‐ 3 days and 64% at 8 ‐ 12 weeks.
Free of other bias? Unclear risk The published paper did not provide information on non significant results; the author provided additional unpublished data on request.