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Misoprostol for the Treatment of Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT00116350
Recruitment Status : Completed
First Posted : June 29, 2005
Last Update Posted : March 19, 2009
Sponsor:
Collaborator:
Family Care International
Information provided by:
Gynuity Health Projects

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Drug: Oxytocin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1786 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Misoprostol for the Treatment of Primary Postpartum Hemorrhage
Study Start Date : July 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Need for additional treatment after initial PPH study treatment [ Time Frame: all additional interventions recorded following initial uterotonic treatment ]

Secondary Outcome Measures :
  1. Mean blood loss after PPH treatment [ Time Frame: blood loss measured for minimum of 1 hour or until active bleeding ceases ]
  2. 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 ]
  3. Time to bleeding cessation [ Time Frame: Time to bleeding cessation recorded ]
  4. Blood transfusion [ Time Frame: any blood transfusion recorded after delivery and prior to discharge ]
  5. Side effects [ Time Frame: any observed or reported side effects recorded following treatment and prior to discharge ]
  6. Acceptability for women [ Time Frame: Exit interview conducted prior to discharge ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116350


Locations
Burkina Faso
Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso
Bobo Diolasso, Burkina Faso
Ecuador
Hospital Gineco-Obstetrico Isidro Ayora
Quito, Ecuador
Egypt
Alexandria University Hospital, Shatby Maternity Hospital
Alexandria, Egypt
El-Galaa Teaching Hospital
Cairo, Egypt
Turkey
Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital
Ankara, Turkey, 06010
Vietnam
Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital
Ho Chi Minh City and Binh Duong Province, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Family Care International
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Jennifer Blum, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Study Director: Sheila Raghavan, M.Sc. Gynuity Health Projects
Study Director: Ayisha Diop, MPH Gynuity Health Projects
Study Director: Ilana Dzuba, M.H.Sc. Gynuity Health Projects
Study Director: Jill Durocher Gynuity Health Projects

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00116350     History of Changes
Other Study ID Numbers: 2.4.1
WIRB #20041878/1063615
First Posted: June 29, 2005    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage
Misoprostol
Developing countries
Maternal morbidity
Randomized controlled trial

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents