Neto 1990.
Methods | Quasi‐randomised controlled trial | |
Participants | 80 women with normal labour and episiotomy in 1 public hospital, recruited between October 1988 and September 1989. | |
Interventions | Intervention arm received oral chloramphenicol 500 mg 4 times daily for 72 hours after episiotomy repair. Control arm received no treatment. | |
Outcomes | A total of 73 women included in analysis, 34 in intervention arm and 39 in control arm. Outcomes measured included episiotomy dehiscence (wound rupture without signs of infection), episiotomy infection (pain, heat, redness, or purulent discharge and wound rupture), and puerperal endometritis assessed at 10 days postpartum (defined as 2 of the following; fever, hypogastric pain, uterine involution, abnormal lochia). | |
Notes | Florianopolis, Brazil. Exclusion of 7 women lost to follow‐up at 10 days postpartum. All women were from low socioeconomic class. All women attended by registrars. Funding: not reported. Conflicts of interest: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Randomised according to protocol number (even and odd numbers) |
Allocation concealment (selection bias) | High risk | Allocation concealment based on protocol number |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not double‐blinded. Control arm received no treatment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unknown. No information on whether physicians who evaluated the women at 10 days postpartum were blinded to the treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6 women in intervention group and 1 in control group were missing for follow‐up, but no differences reported in baseline characteristics among those followed‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Low risk | No other sources of bias noted. |