Greenberg 2004.
Methods | RCT (block randomisation). | |
Participants | Setting ‐ Brigham & Women's Hospital and the Massachusetts General Hospital, USA. 1361 women enrolled ‐ only two‐thirds (n = 908) required suturing of vulval and/or vaginal laceration; and/or episiotomy. Inclusion criteria ‐ women presenting in labour or for induction. Exclusion criteria ‐ not documented. Parity ‐ primigravida and multigravida Maternal age ‐ not documented. Operator ‐ obstetricians and midwives. |
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Interventions | Method of repair ‐ (not fully described) all practitioners used subcuticular skin closure except 1 operator who used interrupted technique. Intervention group (n = 459) ‐ fast‐absorbing polyglactin 910 (gauge of material and needle size not specified). Comparison group (n = 449) ‐ chromic catgut (gauge of material and needle size not specified). | |
Outcomes | INCLUDED IN ANALYSIS Vaginal pain ‐ 24 ‐ 48 hrs; 10‐14 days; 6‐8 weeks postpartum. Uterine pain ‐ 24 ‐ 48 hrs; 10‐14 days; 6‐8 weeks postpartum. Analgesia (used in last 8 hrs) 24 ‐ 48 hrs; 10‐14 days; 6‐8 weeks postpartum. Painless bowel movement ‐ 24 ‐ 48 hrs; 10‐14 days; 6‐8 weeks postpartum. Resuturing ‐ up to day 7. Perineal wound breakdown at 6‐8 weeks. Dyspareunia ‐ at 3 months. | |
Notes | 87% of participants received allocated suture material. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Treatment allocated by block randomisation (block size 10) using validated SAS program (Cary, NC). |
Allocation concealment? | Low risk | Numbered opaque sealed envelopes. |
Blinding? Women | High risk | Stated that 'women were not blinded to suture material used'. |
Blinding? Clinical staff | High risk | Unable to ‘blind’ operators due to obvious difference in suture material. |
Blinding? Outcome assessors | Unclear risk | Stated 'nurses were blinded to suture material used when asking questions at 24‐48 hrs and 10‐14 days postpartum'. |
Incomplete outcome data addressed? All outcomes | Unclear risk | 1361 women randomised, however, only 908 women required perineal repair and were included in analysis. Intention‐to‐treat analysis carried out amongst women who received sutures (women were recruited prior to delivery and therefore some women did not require perineal suturing). 64% of participants were lost to follow up at 6‐8 weeks postpartum. |
Free of other bias? | Unclear risk | Groups appeared similar at baseline. There were some protocol violations but analysis by randomisation group for those women requiring repair. |