Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, with increased risk following cesarean section compared to vaginal delivery. Oxytocin is the standard uterotonic agent used to prevent PPH, but it has several limitations including the need for refrigeration and potential cardiovascular side effects when administered rapidly.
Misoprostol, a prostaglandin E1 analogue, has gained attention as an effective alternative or adjunct to oxytocin because it is heat-stable, inexpensive, widely available in tablet form, and can be administered by various routes. The rectal route is particularly advantageous, providing rapid absorption, sustained uterine contraction, and fewer gastrointestinal side effects. However, its onset of action is slower than oxytocin, which may affect intraoperative hemostasis if uterine tone is not achieved quickly.
This study is designed as a randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Assiut University Hospital. Eligible participants will be women aged 18-45 years with singleton pregnancies at ≥37 weeks of gestation undergoing elective cesarean section. Participants will be randomized into two groups:
Group A (Control): Oxytocin only, given according to hospital protocol immediately after delivery of the baby and placenta.
Group B (Intervention): Oxytocin plus a single rectal dose of misoprostol (600-1000 µg, based on risk profile) administered immediately after delivery of the baby and placenta.
The primary outcome will be the reduction in intraoperative and postoperative blood loss. Secondary outcomes will include changes in pre- and postoperative hemoglobin levels, need for additional uterotonic agents, maternal safety, ease and feasibility of rectal administration, and postoperative recovery.
The total sample size is 282 participants (141 per group), calculated to provide 80% power at a 95% confidence level to detect a significant reduction in blood loss. Data will be analyzed using SPSS software, with chi-square and independent sample t-tests applied as appropriate. Statistical significance will be considered at p < 0.05.
This trial seeks to provide evidence on the effectiveness and practicality of rectal misoprostol as an adjunct to oxytocin for reducing maternal blood loss during elective cesarean section, potentially improving outcomes and cost-effectiveness, particularly in resource-limited settings.
