The efficacy of intrauterine misoprostol during cesarean section in prevention of primary PPH, a randomized controlled trial

Background: Postpartum hemorrhage is the leading cause of maternal mortality worldwide. Aim: To compare the incidence of postpartum hemorrhage in women eligible for elective cesarean section (CS) delivery when using intrauterine misoprostol added to oxytocin versus oxytocin alone. Design, Setting, Participants: This parallel randomized controlled trial study was conducted in two institutions in Egypt (Kasralainy and Aljazeerah hospital) 0.300 women eligible for elective CS delivery were enrolled in the study. Interventions: Before randomization, all women received the same preparations. After randomization; in the study group (N = 150), intrauterine misoprostol was used after placental delivery. In the control group (N = 150), the routine oxytocin alone was used. Results: Both groups were comparable (p-value >.05) with regard to the age, BMI, and gestational age as well as hemoglobin and hematocrit levels. The incidence of postpartum hemorrhage was significantly lower (p = .018) in the study group (1.33%) than the control group (6.67%). The absolute risk reduction was 5.3% (CI 95%: 0.8-10.6%) with a relative risk of 0.20 (CI 95%: 0.05-0.90) and number needed to treat (NNT) 19 (CI 95%: 125-9). Moreover, the needs for a blood transfusion, extra uterotonics or additional interventions were significantly lower in the study group than in the control group (p < .05). All the three parameters of blood loss ie the mean blood loss, and the mean reductions of hemoglobin and hematocrit levels were significantly (p-value <.05) lower in the study group (mean and SD) (442.59 and 151.33 mL,0.46 and 0.3 g/dL, and 0.84 and 0.56%), respectively than in the control group (591.01 and 287.97 mL,1.2 and 1.39 g/dL, and 3.47 and 3.52%), respectively. Adverse events were comparable between groups; these were fever, nausea, and vomiting and shivering. Conclusion: Intrauterine misoprostol (400 mg) when added to oxytocin is safe and effective in decreasing the incidence of postpartum hemorrhage (PPH) and reducing the amount of postpartum blood loss in case of elective CS delivery.