Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

May 30, 2013 updated by: Salah M Rasheed, Sohag University

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.

Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.

Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

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

  • Egypt
      • Sohag, Egypt, 1224
        • Recruiting
        • Sohag University
        • Contact:
        • Principal Investigator:
          • Salah M Rasheed, MD

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • primary atonic postpartum hemorrhage after vaginal delivery

Exclusion Criteria:

  • Patients who delivered by caesarean section
  • Retained placenta
  • Traumatic postpartum hemorrhage
  • Associated coagulopathy
  • Chronic medical illness (hepatic , renal diseases)
  • Refusal to participate in the study.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Oxytocin
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
Drug: oxytocin
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
ACTIVE_COMPARATOR: carbetocin
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
Drug: carbetocin
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
Other Names:
  • pabal
ACTIVE_COMPARATOR: misopristol
600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage
Drug: misopristol
600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage
Other Names:
  • Misotac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
control of postpartum hemorrhage
Time Frame: within 20 minutes of administration
within 20 minutes of administration

Secondary Outcome Measures

Outcome Measure
Time Frame
time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Sohag University

Collaborators

Al-Azhar University

Investigators

  • Study Director: Salah M Rasheed, MD, Department of obstetrics and Gynecology, Sohag university, Egypt
  • Study Chair: magdy M Amin, MD, Department of obstetrics and Gynecology, Sohag university, Egypt
  • Principal Investigator: Ahmed H Abd-Ella, MD, Department of obstetrics and Gynecology, Qena university, Egypt
  • Principal Investigator: Ahmed M Abo Elhassan, MD, Department of obstetrics and Gynecology, Assuit university, Egypt
  • Principal Investigator: Mazen A El Zahry, M.D., Department of Obstetrics and Gynecology, Al Azhar university, Egypt

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

September 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

July 1, 2013

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (ESTIMATE)

May 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • salah-1

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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