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. |
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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). |
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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. |
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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. |