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. |
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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). |
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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. |
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Notes | The authors of this study provided additional unpublished data on outcomes.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risk | The published paper did not provide information on non significant results; the author provided additional unpublished data on request. |