Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean

Phase 2

• Conditions: Bleeding Intraoperative
• Interventions: Drug: Misoprostol

• Registration Number: NCT01477840
• Lead Sponsor: Soudabeh Eshghi ali

Brief Summary

The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.

Detailed Description

A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.

Study Timeline

• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-19
• Study First Posted: 2011-11-23
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-13
• Study Start: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Indication of Cesarean Deliveries
• Elective or Emergency with Incision in Lower Segment in Women with
• Gestational Age more than 37 Weeks.

Exclusion Criteria

• Anemia
• Multiple Pregnancy
• Polyhydraminus
• Prolonged Labor
• Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
• Hypertension
• Cardiovascular Disease
• Coagulopathy Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
Intraoperative bleeding	At the time of surgery

Secondary Outcome Measures

Name	Time	Method
Fever	During 48 hours after surgery measured every 3 hours
Changing of pulse rate from base	Before surgery & intraoperative & 6 hours after surgery
Changing of blood pressure	Before surgery & intraoperative & 6 hours after surgery
Diarrhea	Before & 6 hours after surgery
Vomiting	Before & 6 hours after surgery

Trial Locations

Locations (1)

KUMS Obstetrics & Gynecology Department, Imam Reza Hospital; 🇮🇷 Kermanshah, Iran, Islamic Republic of