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Vaginal cleansing before cesarean delivery in labor to reduce infection: a randomized trial

      Objective

      Surgical site infections following cesarean delivery (CD) are a significant source of postoperative morbidity. Vaginal cleansing prior to CD may reduce infections; however, the quality of evidence regarding efficacy of vaginal preparation is low to moderate. We tested the hypothesis that preoperative vaginal cleansing with povidone-iodine among women undergoing CD after labor would decrease postoperative infectious morbidity.

      Study Design

      This was a randomized controlled trial. Patients undergoing CD after labor were randomly assigned to preoperative abdominal cleansing only or preoperative abdominal cleansing plus vaginal cleansing with povidone iodine. Patients met inclusion criteria if they underwent CD after regular contractions and any cervical dilation, if they had rupture of membranes, or had CD performed at >4 cm dilation. The primary outcome was composite infectious morbidity including surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after CD. Secondary outcomes included hospital readmission, ED visits, and treatment for neonatal sepsis. We estimated a priori that 610 subjects would provide 80% power to detect a 60% reduction in primary outcome from a baseline of 10% in a 2-sided test (p= 0.045 to account for 1 interim analysis).

      Results

      608 subjects (299 vaginal cleansing group, 309 control group) were included in the intention-to-treat analysis. Patient characteristics were similar between groups. There was no significant difference in the primary composite outcome between the two groups (11.7% vs 11.7%, p=0.98, RR 1.0; 95% CI 0.6, 1.5). Individual components of the composite and secondary outcomes also did not significantly differ between groups. Similar findings were observed in the per protocol analysis (11.3% vs 11.8%, p=0.83, RR 1.0; 95% CI 0.6, 1.5).

      Conclusion

      Vaginal cleansing with povidone-iodine prior to unscheduled CD occurring after labor did not reduce postoperative infectious morbidity. Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed.
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