Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

Phase 2

Completed

• Conditions: Neonatal Outcome
• Interventions: Drug: Misoprostol; Other: Placebo

• Registration Number: NCT03148717
• 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 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.

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 First Submitted: 2017-04-29
• Study Start: 2017-05-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Status Verified: 2018-03
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-20
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Patients candidate for cesarean section.
2. Full term pregnancies (GA 37- 42 Wks).
3. Age (18-40 yrs).
4. body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteia:

1. Contraindication to spinal anesthesia.
2. Blood dyscrasias.
3. Large fibroids.
4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
5. Emergency CS such as fetal distress
6. Extreme of BMI (<20 or >30 Kg/m2 ).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neonatal outcome	5 minutes	measured by APGAR score at 5 minutes

Secondary Outcome Measures

Name	Time	Method
NICU admission	24 hours	Number of neonates admitted to NICU within 24 hours.
amount of blood loss	24 hours
Postpartum hemorrhage	24 hours
Need for extra uterotonics	24 hours

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt