Effect of Preoperative Vaginal Cleansing With Povidone Iodine on Post-caesarean Maternal Infections at Kenyatta National Hospital; a Randomized Controlled Trial

Abstract

Maternal sepsis accounts for 11% of maternal mortality. Caesarean section is the single most important factor for postpartum maternal infection. Despite different strategies implemented to reduce postcaesarean maternal infection, it is still common, and increases costs of treatment, length of hospital stay and maternal morbidity and mortality. Preoperative vaginal preparation with povidone iodine before caesarean section may reduce postcaesarean maternal infection. We studied preoperative vaginal cleansing with povidone iodine to reduce post-caesarean maternal infection. Objectives In the current study, we aimed to find out if preoperative vaginal cleansing with povidone iodine can reduce postcaesarean maternal infection among women receiving postoperative vaginal toilet with povidone iodine at Kenyatta National Hospital. The primary outcome was overall maternal infection including endometritis, fever and surgical site infection. We conducted sub-group analysis to evaluate the effect of povidone iodine on endometritis, fever and surgical site infection. Methods This was a randomized controlled trial that was carried out at Kenyatta National Hospital Maternity theatre, post-natal wards and postnatal clinic. We enrolled 397 pregnant women scheduled for both elective and emergency caesarean delivery at gestational age of ≥28weeks. Of these, 194 women were randomized in to the intervention group [preoperative vaginal cleansing group], while 191 in to the control group [no preoperative vaginal cleansing group]. All women received postoperative vaginal cleansing/toilet with povidone iodine as standard practice at Kenyatta National Hospital. We followed participants for 2 weeks postpartum for development of endometritis, fever and surgical site infection. Statistical analysis was done as per protocol with intent-to-treat approach. Proportions were compared using Chi2 test, 95% CI, two tailed hypothesis with p value considered significant at <0.05. Results The groups were similar in socio-demographic characteristics [age, education level, marital status]. There was no difference between the groups in obstetric and labor characteristics [type of labor, duration of labor, status of membranes and duration of membrane rupture, indication and type of caesarean section done].

There was a significant difference in the incidence of overall maternal infection [the sum of endometritis, fever surgical site infection] among women in the preoperative vaginal cleansing arm, compared to the arm without preoperative vaginal cleansing [7.77% vs. 15.81%, p=0.015]. In the subgroup analysis, there was a non-statistically significant reduction in postcaesarean endometritis [0.97%, 2/201] in the preoperative vaginal cleansing arm, and 3.57% [7/196] in the control arm [p=0.089]. Similarly there was no statistically significant difference in postcaesarean fever [p=0.171] and surgical site infection [p=0.186] between the two arms. There was also no statistically significant reduction in postcaesarean endometritis among women in established labor [1.67% vs. 4.17%; p=0.446], with ruptured membranes [1.14% vs. 5.49%; p=0.108] and emergency caesarean delivery patients [1.18% vs. 4.09%; p=0.093] between the preoperative and no preoperative vaginal cleansing arms respectively. Conclusion Preoperative vaginal cleansing with povidone iodine reduces the overall maternal infection but not postcaesarean endometritis, fever or surgical site infection among women who undergo postcaesarean vaginal cleansing/toilet at Kenyatta National Hospital. Preoperative cleansing with povidone iodine in addition to postoperative cleansing with povidone iodine does not alter postcaesarean endometritis in women with established labor, ruptured membranes and emergency caesarean section. Preoperative or postoperative povidone iodine did not show any major side effects/local reaction to the vaginal mucosa. Recommendations Consistent with the WHO recommendations, preoperative vaginal cleansing with povidone iodine should be considered as an intervention for reducing postcaesarean maternal infection in women even if they undergo postcaesarean vaginal cleansing/toilet with povidone iodine. Further studies with larger sample sizes are needed to evaluate the benefit of preoperative vaginal cleansing on the incidence of endometritis at 2 weeks and up to 6 weeks postpartum. Since postoperative vaginal cleansing is the standard of care at KNH, it is also important to evaluate its effectiveness compared to preoperative vaginal cleansing.