Misoprostol for the Treatment of Postpartum Hemorrhage

March 17, 2009 updated by: Gynuity Health Projects

Misoprostol for the Treatment of Primary Postpartum Hemorrhage

The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.

Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:

  • Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?
  • Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?
  • Is the side effect profile of misoprostol acceptable to women?

This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.

Study Type

Interventional

Enrollment (Actual)

1786

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

  • Burkina Faso
      • Bobo Diolasso, Burkina Faso
        • Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso
  • Ecuador
      • Quito, Ecuador
        • Hospital Gineco-Obstétrico Isidro Ayora
  • Egypt
      • Alexandria, Egypt
        • Alexandria University Hospital, Shatby Maternity Hospital
      • Cairo, Egypt
        • El-Galaa Teaching Hospital
  • Turkey
      • Ankara, Turkey, 06010
        • Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital
  • Vietnam
      • Ho Chi Minh City and Binh Duong Province, Vietnam
        • Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Vaginal delivery
  • Postpartum hemorrhage due to suspected uterine atony
  • Depending on study group: administration of prophylactic uterotonics in third stage of labor

Exclusion Criteria:

  • Known allergy to misoprostol or other prostaglandin
  • C-section for current delivery

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
800 mcg sublingual misoprostol
Drug: Misoprostol
800 mcg sublingual misoprostol
Active Comparator: Oxytocin
40 IU Oxytocin IV
Drug: Oxytocin
40 IU Oxytocin IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for additional treatment after initial PPH study treatment
Time Frame: all additional interventions recorded following initial uterotonic treatment
all additional interventions recorded following initial uterotonic treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean blood loss after PPH treatment
Time Frame: blood loss measured for minimum of 1 hour or until active bleeding ceases
blood loss measured for minimum of 1 hour or until active bleeding ceases
Change in hemoglobin from pre-delivery to postpartum
Time Frame: Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV
Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV
Time to bleeding cessation
Time Frame: Time to bleeding cessation recorded
Time to bleeding cessation recorded
Blood transfusion
Time Frame: any blood transfusion recorded after delivery and prior to discharge
any blood transfusion recorded after delivery and prior to discharge
Side effects
Time Frame: any observed or reported side effects recorded following treatment and prior to discharge
any observed or reported side effects recorded following treatment and prior to discharge
Acceptability for women
Time Frame: Exit interview conducted prior to discharge
Exit interview conducted prior to discharge

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Collaborators

Family Care International

Investigators

  • Study Director: Sheila Raghavan, M.Sc., Gynuity Health Projects
  • Study Director: Jennifer Blum, MPH, Gynuity Health Projects
  • Study Director: Ilana Dzuba, M.H.Sc., Gynuity Health Projects

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

Helpful Links

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

July 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

June 28, 2005

First Submitted That Met QC Criteria

June 28, 2005

First Posted (Estimate)

June 29, 2005

Study Record Updates

Last Update Posted (Estimate)

March 19, 2009

Last Update Submitted That Met QC Criteria

March 17, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.4.1
  • WIRB #20041878/1063615

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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