McElhinney 2000.
Methods | RCT. | |
Participants | Setting ‐ Ulster Hospital, Dundonald, Northern Ireland, UK. 153 women randomised. Inclusion criteria ‐ women with a parity of 0 to 2; between 18 and 40 years of age; singleton fetus; had a normal vaginal delivery and required an episiotomy or had sustained a second degree tear (skin and perineal muscle). Exclusion criteria ‐ not documented. Parity ‐ primigravida and multigravida. Maternal age ‐ 18 to 40 years. Operator ‐ not documented. |
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Interventions | Method of repair ‐ all repairs carried out using the same technique with 1 length of suture material and subcuticular perineal skin closure. Method not fully described. Intervention group (n = 75) ‐ fast‐absorbing polyglactin 910 (Vicryl Rapide) (gauge of material and needle size not specified). Comparison group (n = 78) ‐ standard polyglactin 910 (Vicryl) (gauge of material and needle size not specified). | |
Outcomes | Perineal pain ‐ 24 hrs and 3 days. Analgesia at 3 days. Wound infection, gaping wound (no data), suture removal ‐ 6 and 12 weeks. Dyspareunia ‐ 6 and 12 weeks postpartum. |
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Notes | All women received a diclofenac suppository (100 mg) for pain relief, following completion of the repair. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Treatment allocated by block randomisation (block size not clear). |
Allocation concealment? | Unclear risk | "Two sets of sealed envelopes." |
Blinding? Women | Unclear risk | Not stated. |
Blinding? Clinical staff | Unclear risk | Not stated, however, this would be difficult due to possible differences in suture materials. |
Blinding? Outcome assessors | Unclear risk | Not stated. |
Incomplete outcome data addressed? All outcomes | Unclear risk | 77% of participants followed up at 12 weeks. |
Free of other bias? | Unclear risk | Non‐significant results were not reported in full (stated that differences were not significant). |