Al Inany 2002.
| Methods | Randomised controlled trial. 2:1 randomisation (drain: no drain). | |
| Participants | 120 obese women undergoing caesarean section with a body mass index of more than 32.
80 women in the drain group and 40 women in the 'no drain' group.
2 women were excluded because they left the hospital after two days and did not complete follow‐up. Excluded if: pre‐labour caesarean section; prolonged pre‐labour rupture of membranes; prolonged labour; "long pre‐operative hospitalisation"; chronic illness. Included if: first or repeat caesarean; intrapartum caesarean. All skin incisions were Pfannenstiel incisions. No subcutaneous sutures were used. |
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| Interventions | Treatment group: subcutaneous suction drain.
Control group: no subcutaneous drain. Drains were left in for 24 hours or until the drainage was <50 ml (time period not specified). |
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| Outcomes | Wound breakdown, wound haematoma and post‐operative febrile morbidity (> 38.5C, >24 hours and < 5 days) incidence available on 118 women. Wounds assessed prior to discharge, 5‐7 days post‐operatively and at 3 weeks. | |
| Notes | Trial conducted in Egypt 1999 to 2000. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information. |
| Allocation concealment (selection bias) | Unclear risk | "Participants were allocated using sealed envelopes" ‐ numbering, opacity or method of using sealed envelopes not mentioned, not whether all envelopes were accounted for. |
| Blinding (performance bias and detection bias) Women | High risk | Not mentioned, assumed not done. |
| Blinding (performance bias and detection bias) Clinicians: surgeons and midwives | High risk | Not possible. |
| Blinding (performance bias and detection bias) Outcome assessment | Unclear risk | No information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | We have assumed that the two women "excluded from the study" had been randomised. 120 randomised, outcome data for 118. |
| Other bias | Low risk | |