Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Misoprostol
- Conditions
- Cesarean Section
- Sponsor
- Ain Shams University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Need for extra uterotonics
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.
Investigators
Mohamed S Sweed, MD
Assistant Professor
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Patients booked for elective cesarean section.
- •Singleton pregnancies.
- •Full term pregnancies (GA 37- 42 Wks).
- •Age (18-40 yrs).
- •body mass index (BMI) (20-30(Kg/m2 .
Exclusion Criteria
- •Contraindication to spinal anesthesia.
- •Blood dyscrasias.
- •Large fibroids.
- •Multiple pregnancies.
- •Overdistended uterus eg. Hydramnios.
- •Pre-eclampsia.
- •Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl).
- •Previous history of PPH.
- •Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- •Placenta previa.
Arms & Interventions
Preoperative
• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
Intervention: Misoprostol
Preoperative
• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
Intervention: Placebo
Postoperative
• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .
Intervention: Misoprostol
Postoperative
• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .
Intervention: Placebo
Outcomes
Primary Outcomes
Need for extra uterotonics
Time Frame: 24 hours
Secondary Outcomes
- postpartum hemorrhage(24 hours)
- intraoperative blood loss(intraoperative)
- neonatal outcome(5 minutes)