| Methods | RCT. | |
| Participants | Inclusion: pregnant women schedule for term elective cesarean section ‐ indications were prior cesarean, abnormal presentation, maternal request, prior cystocele repair or prior perineal tear Exclusion: emergency cesarean, premature ruptured membranes, placenta previa, immunocompromised status. Setting: Saudi Arabia |
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| Interventions | Intervention: chlorhexidine 0.25% antiseptic wipes in vagina (3 10 cm x 10 cm pieces used from apex to introitus including fornices for approximately 1 minute total time). Control: no vaginal cleansing. Intention‐to‐treat analysis. |
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| Outcomes | Outcomes: infectious morbidities – endometritis, fever, wound infection. Endometritis ‐ fever with tenderness and offensive lochia. Febrile morbidity ‐ fever of 38 degrees C or more without infectious clinical findings. Wound infection ‐ erythema or wound edge separation with purulent discharge requiring antibiotics and wound care. Side effects |
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| Notes | All outcomes are summed for overall results. Apparently no one with endometritis also had a wound infection. These are not necessarily mutually exclusive. October 2014 to end of December 2015. Funding source: not stated Author declarations of interest: no conflicts of interest |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Simple randomization method used. |
| Allocation concealment (selection bias) | Unclear risk | No other information provided beside the use of sealed envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Vaginal scrub was performed while the surgeon was in the room. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Clinical care team was blinded to either arm. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 in intervention and 11 in control arm lost to follow‐up. Otherwise, complete outcome data. |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
| Other bias | Low risk | None |