Rogers 1974.
Methods | RCT. | |
Participants | Setting ‐ Department of Obstetrics and Gynecology, Madigan Army Centre, Tacoma, Washington, USA. 600 women randomised. Inclusion criteria ‐ women who had a median and medio‐lateral episiotomies (episiotomies with lacerations also included). Exclusion criteria ‐ not documented. Method of delivery ‐ not clear, defined as complicated or not complicated. Parity ‐ not specified. Mean age ‐ intervention group = 23.45; comparison group = 22.81. Operators ‐ not specified. |
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Interventions | Method of repair ‐ not described.
Intervention group (n = 301) sutured with chromic catgut (gauge 3‐0), needle size not specified. Comparison group (n = 299) sutured with polyglycolic acid (Dexon) (gauge 3‐0), needle size not specified. |
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Outcomes | Short‐term pain ‐ period of time not specified. Pain in relation to type of episiotomy. Wound healing at 6 weeks' postpartum (unsure how this was assessed/followed up). | |
Notes | Period of follow up not specified. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Allocated using 'random technique'. |
Allocation concealment? | Unclear risk | Suture packs were inside sealed plain envelopes. |
Blinding? Women | Unclear risk | Not documented. |
Blinding? Clinical staff | Unclear risk | Not documented, however, this would be difficult due to differences in suture materials. |
Blinding? Outcome assessors | Unclear risk | Not documented, however, this would be difficult due to differences in suture materials. |
Incomplete outcome data addressed? All outcomes | Low risk | All participants entered into the trial were included in the analysis. |
Free of other bias? | Low risk | No baseline imbalance apparent. |