Beard 1974.
Methods | RCT. | |
Participants | Setting ‐ Queen Charlotte Maternity Hospital, London, UK. 200 women 'allocated randomly' into 2 groups. Inclusion criteria ‐ women having a 'normal delivery' with an episiotomy. Exclusion criteria ‐ women with lacerations or those booked for 48 hour discharge. Parity ‐ primigravidae and multigravidae. Mean age ‐ not specified. Operator ‐ resident obstetric officers in their second obstetric appointment. |
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Interventions | Intervention group (n = 100) ‐ 'standard method of repair incorporating a subcuticular suture to the perineal skin' with polyglycolic acid (Dexon) 2‐0 suture material on a 40 mm round bodied atraumatic needle. Comparison group (n = 100) ‐ 'standard method of repair incorporating a subcuticular suture to the perineal skin' with chromic catgut 2‐0 suture material on a 55 mm 'loose' round bodied needle. | |
Outcomes | Short‐term pain ‐ day 3. Analgesia ‐ day 3. Suture dehiscence ‐ day 3 (classified as superficial and deep). Wound inflammation ‐ day 3. | |
Notes | Similar number of primigravida and multigravida women in each group. Method of repair not fully described. It was documented in the paper that on the 3rd day after delivery the patients were interviewed and examined by 1 of the operators without knowledge of which suture material had been used. This may have been possible if the skin was closed with a subcuticular suture as the stitches would not be visible. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Allocated "randomly to two groups" ‐ method not described. |
Allocation concealment? | Unclear risk | No information available regarding concealment of treatment allocation. |
Blinding? Women | Unclear risk | No details given. |
Blinding? Clinical staff | High risk | Difference in suture materials and needles used for the repairs. |
Blinding? Outcome assessors | Unclear risk | Outcome assessors were described as being "without knowledge of which suture had been used". |
Incomplete outcome data addressed? All outcomes | Low risk | All participants entered into the trial were included in the analysis. |
Free of other bias? | Unclear risk | Outcomes relating to pain were not simple to interpret, for 1 measure of pain, event rates added up to more than the total sample size and women may have been counted more than once: this outcome has not been included in the review. |