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. 2010 Jun 16;2010(6):CD000006. doi: 10.1002/14651858.CD000006.pub2

McElhinney 2000.

Methods RCT.
Participants Setting ‐ Ulster Hospital, Dundonald, Northern Ireland, UK.
153 women randomised.
Inclusion criteria ‐ women with a parity of 0 to 2; between 18 and 40 years of age; singleton fetus; had a normal vaginal delivery and required an episiotomy or had sustained a second degree tear (skin and perineal muscle).
Exclusion criteria ‐ not documented.
Parity ‐  primigravida and multigravida. 
 Maternal age ‐ 18 to 40 years. 
 Operator ‐ not documented.
Interventions Method of repair ‐ all repairs carried out using the same technique with 1 length of suture material and subcuticular perineal skin closure. Method not fully described. 
 Intervention group (n = 75) ‐ fast‐absorbing polyglactin 910 (Vicryl Rapide) (gauge of material and needle size not specified). 
 Comparison group (n = 78) ‐ standard polyglactin 910 (Vicryl) (gauge of material and needle size not specified).
Outcomes Perineal pain ‐ 24 hrs and 3 days.
Analgesia at 3 days. 
 Wound infection, gaping wound (no data), suture removal ‐ 6 and 12 weeks.
Dyspareunia ‐ 6 and 12 weeks postpartum.
Notes All women received a diclofenac suppository (100 mg) for pain relief, following completion of the repair.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Treatment allocated by block randomisation (block size not clear).
Allocation concealment? Unclear risk "Two sets of sealed envelopes."
Blinding? 
 Women Unclear risk Not stated.
Blinding? 
 Clinical staff Unclear risk Not stated, however, this would be difficult due to possible differences in suture materials.
Blinding? 
 Outcome assessors Unclear risk Not stated.
Incomplete outcome data addressed? 
 All outcomes Unclear risk 77% of participants followed up at 12 weeks.
Free of other bias? Unclear risk Non‐significant results were not reported in full (stated that differences were not significant).