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

December 12, 2011 updated by: Soudabeh Eshghi ali

Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Kermanshah, Iran, Islamic Republic of, 67144-15333
        • KUMS Obstetrics & Gynecology Department, Imam Reza Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 44 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Misoprostol
Drug: Misoprostol
Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia
Other Names:
  • Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative bleeding
Time Frame: At the time of surgery
At the time of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soudabeh Eshghi ali

Collaborators

Kermanshah University of Medical Sciences

Investigators

  • Study Chair: Anisodowleh Nankali, MD, Kermanshah University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 19, 2011

First Posted (ESTIMATE)

November 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kermanshah University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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