Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Phase 2

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Misoprostol; Other: Placebo

• Registration Number: NCT03144401
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-04-29
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Primary Completion: 2018-01-12
• Study Completion: 2018-02-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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.
• Previous myomectomy.
• Extreme of BMI (<20 or >30 Kg/m2 ).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative	Misoprostol	• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
Postoperative	Placebo	• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .
Preoperative	Placebo	• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
Postoperative	Misoprostol	• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .

Primary Outcome Measures

Name	Time	Method
Need for extra uterotonics	24 hours

Secondary Outcome Measures

Name	Time	Method
postpartum hemorrhage	24 hours
intraoperative blood loss	intraoperative
neonatal outcome	5 minutes	measured by APGAR score at 1 and 5 minutes

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt