Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Misoprostol
- Conditions
- Neonatal Outcome
- Sponsor
- Ain Shams University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Neonatal outcome
- 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 December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.
- 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 candidate for cesarean section.
- •Full term pregnancies (GA 37- 42 Wks).
- •Age (18-40 yrs).
- •body mass index (BMI) (20-30(Kg/m2 .
- •Exclusion Criteia:
- •Contraindication to spinal anesthesia.
- •Blood dyscrasias.
- •Large fibroids.
- •Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- •Emergency CS such as fetal distress
Exclusion Criteria
- Not provided
Arms & Interventions
Preoperative
Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".
Intervention: Misoprostol
Preoperative
Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".
Intervention: Placebo
Postoperative
Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .
Intervention: Misoprostol
Postoperative
Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .
Intervention: Placebo
Outcomes
Primary Outcomes
Neonatal outcome
Time Frame: 5 minutes
measured by APGAR score at 5 minutes
Secondary Outcomes
- NICU admission(24 hours)
- amount of blood loss(24 hours)
- Postpartum hemorrhage(24 hours)
- Need for extra uterotonics(24 hours)