Roberts 1983.
Methods | RCT. | |
Participants | Setting ‐ Stobhill General Hospital, Glasgow, UK. 190 women randomised. Inclusion criteria ‐ all women who had either a spontaneous vaginal delivery or forceps with an episiotomy. Exclusion criteria ‐ no details given. Parity ‐ not stated.. Mean age ‐ not specified. Operator ‐ not clear. |
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Interventions | Method of repair ‐ continuous suture to close vaginal epithelium and interrupted sutures for muscle layers and skin (buried knots). Intervention group (n = 88) vagina and muscle sutured with polyglycolic acid (Dexon gauge1‐0) and skin sutured with polyglycolic acid (Dexon gauge2‐0) using an interrupted technique and buried knots. Comparison group (n = 84) vagina and muscle sutured with chromic catgut (gauge1‐0) and skin sutured with plain catgut (gauge 2‐0) using an interrupted technique and buried knots. |
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Outcomes | Short‐term pain on rest ‐ 1 to 10 days. Short‐term pain on movement ‐ 1 to 10 days. Analgesia ‐ up to day 5. Bruising ‐ day 2 and 4. Oedema ‐ day 2 and 4. |
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Notes | Not clear if all repairs were carried out by a single investigator. Patients were assessed daily for 5 days after delivery by the obstetrician. Assessed at home on tenth day by district midwife. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Allocated by a "randomisation schedule". |
Allocation concealment? | Unclear risk | No information available regarding concealment of treatment allocation. |
Blinding? Women | Unclear risk | Described as "double‐blind trial". |
Blinding? Clinical staff | Unclear risk | This would be difficult due to differences in suture materials |
Blinding? Outcome assessors | Unclear risk | This would be difficult due to differences in suture materials. |
Incomplete outcome data addressed? All outcomes | Unclear risk | 18 of 190 women randomised were excluded from the analysis because 'they were unable to complete the study due to being discharged early or tablets were lost'. Authors state that loss was balanced across groups. |
Free of other bias? | Unclear risk | Women in the 2 study groups were described as having similar characteristics. |