Saint 1993.

Methods	Randomised trial.
Participants	Setting ‐ Princess Anne Wing, Royal United Hospital, Bath, UK. 1000 women randomised. Inclusion criteria ‐ women who delivered spontaneously or with assistance with perineal trauma 'deemed worthy of repair'. Exclusion criteria ‐ women with third degree tear. Parity ‐ not specified. Mean age ‐ not specified. Operators ‐ midwives and doctors.
Interventions	Method of repair ‐ continuous suture to close posterior vaginal wall, deeper layer were opposed with interrupted stitches and skin closed with interrupted or continuous subcuticular (depending on operator's preference). The actual number of women allocated to each group is not stated. Intervention group ‐ glycerol‐impregnated catgut (Softgut, no details given regarding gauge of suture material or size of needle). Comparison group ‐ untreated chromic catgut (no details given regarding gauge of suture material or size of needle).
Outcomes	Pain at 24 hours; 10 days; 6 weeks; 3 and 6 months postpartum. Dyspareunia at 3 and 6 months postpartum.
Notes	No description of the groups at trial entry to assess if baseline data were similar. There was also no description of the actual intervention received.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	'Randomly allocated.'
Allocation concealment?	Unclear risk	Very little information provided on study methods.
Blinding? Women	Unclear risk	Not stated.
Blinding? Clinical staff	Unclear risk	Not stated.
Blinding? Outcome assessors	Unclear risk	Not stated.
Incomplete outcome data addressed? All outcomes	Unclear risk	Loss to follow up was not clear but there was missing data at all data collection points (10 ‐ 15% missing data).
Free of other bias?	Unclear risk	Insufficient information on methods.