Banninger 1978.
Methods | Quasi‐randomised trial. Factorial design (3 arm trial, 2 arms compared different materials (polyglycolic acid vs catgut) using the same method of repair; the third arm included mixed materials and mixed methods of repair; we have not included this arm in the analyses). |
|
Participants | Setting ‐ Zurich, Switzerland. 153 women ‐ these were women in 2 arms of a 3‐arm trial and included only those women who had the same suture material (either polyglycolic acid or catgut) and the same technique (as described below) used throughout the repair. Inclusion criteria ‐ women with an episiotomy and without complications. Exclusion criteria ‐ women with a past history of obstetric operations; breech deliveries and those with additional damage to the cervix, vagina and perineum. Parity ‐ primigravida (first‐time mothers). Mean age ‐ intervention group = 24.1; comparison group = 25.2. Operator ‐ doctors. |
|
Interventions | Intervention group (n = 80) ‐ vagina, perineal muscle and skin sutured using the interrupted technique with polyglycolic acid (Dexon) No. 2‐0 on a 60 mm round bodied needle. Comparison group (n =73) ‐ vagina, perineal muscle and skin sutured using the interrupted technique with chromic catgut No. 0 on a 60 mm round bodied needle. |
|
Outcomes | Short‐term pain ‐ day 3 and 7. Analgesia ‐ up to day 7. Suture dehiscence ‐ up to day 7. Resuturing ‐ up to day 7. Dyspareunia ‐ at 3 months. | |
Notes | Only one‐third of participants followed up at 3 months. Cosmetic results were reported at 3 months after delivery (data not included in the paper) ‐ the intervention group had less scarring in the form of 'rope ladder' compared to the comparison group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | High risk | Allocated by 'alternating sequence'. |
Allocation concealment? | High risk | No information available regarding concealment of treatment allocation, but the alternating randomisation sequence means that group allocation may have been anticipated. |
Blinding? Women | Unclear risk | No details given. |
Blinding? Clinical staff | High risk | Difference in suture material appearance. |
Blinding? Outcome assessors | High risk | Difference in suture material appearance. |
Incomplete outcome data addressed? All outcomes | High risk | Low attrition for short‐term outcomes. At 3 months follow up only 30% of the original sample remained. |
Free of other bias? | Unclear risk | No baseline imbalance apparent. |