Spencer 1986.
Methods | RCT. | |
Participants | Setting ‐ Royal Berkshire Hospital, Reading, UK. 737 women randomised. Inclusion criteria ‐ women requiring perineal repair (including episiotomies and lacerations). Exclusion criteria ‐ not documented. Parity ‐ primigravida and multigravida. Mean age ‐ intervention group = 26.5; comparison group = 27.1. Operators ‐ doctors and supervised medical students. |
|
Interventions | Method of repair ‐ continuous suture to repair the vagina and interrupted sutures to oppose the deeper tissues. The perineal skin was closed with either interrupted or subcuticular as preferred by the operators (each operator used the same technique regardless of the material used). Intervention group ‐ (n = 377) glycerol‐impregnated catgut (Softgut, gauge 2‐0 on a 37 mm diamond point half circle needle). Comparison group ‐ (n = 360) untreated chromic catgut (gauge 2‐0 on a 35 mm taper cut half circle needle). |
|
Outcomes | Pain at 10 days and 3 months postpartum. Removal of suture material at 10 days and 3 months. Healing by secondary intention and perineal breakdown at 10 days, resuturing by 3 months. Dyspareunia at 3 months postpartum. |
|
Notes | Data were analysed primarily by allocated suture material group. Secondary analysis based on suture material actually used and on technique of repair were also performed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomly allocated. |
Allocation concealment? | Unclear risk | Not stated. |
Blinding? Women | Low risk | 'Women were unaware of the allocated suture material.' |
Blinding? Clinical staff | Unclear risk | Not stated. |
Blinding? Outcome assessors | Low risk | 'Community midwives were unaware of the allocated suture material.' |
Incomplete outcome data addressed? All outcomes | Unclear risk | 89% response rate at 10 days, 70% at 3 years. |
Free of other bias? | Low risk | No baseline imbalance apparent. |