Upton 2002.
| Methods | RCT. | |
| Participants | Setting ‐ King George V Memorial Tertiary Hospital, Sydney, Australia. 391 women randomised. Inclusion criteria ‐ women with live singleton birth at > 34 weeks' gestation with a spontaneous vaginal birth requiring perineal repair (first or second degree tear or episiotomy ‐ median or mediolateral). Exclusion criteria ‐ women who had an instrumental delivery; third degree tear or needing repair by medical officer. Parity ‐ primigravida and multigravida. Mean age ‐ intervention group = 29.6; comparison group = 29.5. Operator ‐ midwives. |
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| Interventions | Method of repair ‐ standard closure technique with interlocking suture to close vaginal tissue, interrupted stitching to perineal muscle and continuous subcuticular closure to close the skin. The same suture material was used to close all layers. Intervention group (n = 194) ‐ coated polyglycolic suture material (gauge 2‐0 on a 40 mm, half‐circle taper needle). Comparison group (n = 197) ‐ chromic catgut (gauge 2‐0 on a 40 mm, half‐circle taper needle). |
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| Outcomes | Perineal pain at day 1, day 3, 6 weeks, 3 and 6 months. Wound infection at 6 weeks. Resuturing at 6 weeks. Intercourse resumption at 6 weeks, 3 and 6 months. Dyspareunia at 6 weeks, 3 and 6 months. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Random number generator. |
| Allocation concealment? | Low risk | Sealed, numbered opaque envelopes. |
| Blinding? Women | Low risk | Described as "blinded". |
| Blinding? Clinical staff | High risk | Not feasible. Different suture materials. |
| Blinding? Outcome assessors | High risk | Not feasible. Different suture materials. |
| Incomplete outcome data addressed? All outcomes | Unclear risk | Day 1 follow up 89%, day 3 96%, 81% at 6 months. Missing data for some outcomes. |
| Free of other bias? | Unclear risk | Some baseline imbalance (e.g. there were more primiparous women in the synthetic suture group (54.6%) vs 40% in the catgut group; the authors carried out further analysis to adjust for this). |
mm: millimetre RCT: randomised controlled trial vs: versus