Almeida 2008.
Methods | RCT (individual randomisation). | |
Participants | Setting: birth centre in a general hospital in Brazil. Dates of recruitment: July 2001 to April 2002. 61 women requiring perineal repair after episiotomy or second‐degree tear. Parity: primigravid and multigravid women included (16/31 in group 1 and 15/30 in group 2 had had a previous vaginal delivery). Mean age: group 1 = 24.2 years; group 2 = 24.2 years. Operator: 1 of 10 trained nurse/midwives. |
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Interventions | Method of repair: described as below. Women divided into 2 groups. Group 1 (N = 31),vaginal trauma and perineal muscle re‐approximated with the continuous non‐locking suture technique using polyglactin 910 (Vicryl Rapide) on a 1/2 circle, taper point needle (4 or 5 cm). The skin was approximated separately with a continuous intradermal suture using a 3/8 circle, reverse cutting needle. Group 2 (N = 30), vaginal trauma continuous locking and perineal muscle sutured using the interrupted technique with polyglactin 910 (Vicryl Rapide) using a 1/2 circle needle, taper point of 4 or 5 cm The skin was approximated separately with a 3/8 circle reverse cut needle of 3 cm using interrupted sutures. | |
Outcomes | Included in analysis:
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Notes | Women in both groups had antisepsis of the vulva and perineum. Data collection from women by interview by researcher or midwife. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Described as by "electronic table". |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Clinical staff | High risk | Different techniques used. |
Blinding (performance bias and detection bias) Women | High risk | Different techniques. |
Blinding (performance bias and detection bias) Outcome assessors | High risk | Method used would be recorded in notes. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Randomisation was "applied at the moment of delivery to 95 women. A total of 34 women were excluded from the study and replaced by others according to the randomization table". It was not clear whether women were excluded after randomisation. |
Selective reporting (reporting bias) | Unclear risk | Not apparent. |
Other bias | Unclear risk | Data collection from women by interview by researcher or midwife. There was some baseline imbalance. |