Croce 1997.
Methods | RCT. | |
Participants | Setting: single centre (Codogno Civic Hospital, Italy). 202 women with selective episiotomy. Mean age: group A = 29.5 years; group B = 27.7 years. Operator: not stated. |
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Interventions | Method of repair: as described below. Women divided into 2 groups. Group 1 (N = 100), vaginal trauma sutured with a continuous (Guilmen‐Pontonnier technique) with catgut. Group 2 (N = 102), interrupted (Blair‐Donatti technique) with catgut. | |
Outcomes | Included in analysis:
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Notes | Method of repair: described. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Allocated by 'randomisation' but matched for age, socioeconomic status and parity. |
Allocation concealment (selection bias) | Unclear risk | No information available regarding concealment of treatment allocation. |
Blinding (performance bias and detection bias) Clinical staff | High risk | Different suture techniques. |
Blinding (performance bias and detection bias) Women | High risk | Not stated but women may have been aware of suturing technique. |
Blinding (performance bias and detection bias) Outcome assessors | High risk | Not stated but assessment was likely to have included perineal examination. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Analyses apparently ITT (202 women included in the analyses) but it was not clear how many women were originally randomised. |
Selective reporting (reporting bias) | Unclear risk | Not apparent. |