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RCT of Misoprostol for Postpartum Hemorrhage in India

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ClinicalTrials.gov Identifier: NCT00097123
Recruitment Status : Completed
First Posted : November 18, 2004
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.

Condition or disease Intervention/treatment
Postpartum Hemorrhage Pregnancy Drug: Misoprostol

Detailed Description:

Despite existing knowledge of ways to effectively treat postpartum hemorrhage (PPH), lack of resources in rural India has impeded improvement in rates of maternal mortality and morbidity. Most births take place at home, and local auxiliary nurse midwives are not trained or certified to administer injectable uterotonics. Reduction in postpartum hemorrhage may decrease other adverse maternal outcomes such as the need for additional uterotonic agents, blood transfusion, surgical intervention or death. The main hypothesis of the study is that misoprostol administered orally during the third stage of labor will significantly reduce the incidence of acute postpartum hemorrhage. The advantages of misoprostol are: that it is relatively inexpensive, is an oral preparation of 600 mcg with a long shelf life, and does not require refrigeration. One thousand six hundred women giving birth in selected sites in Belgaum District, Karnataka, India will be randomly assigned to misoprostol or placebo. The primary outcome is the incidence of acute postpartum hemorrhage; secondary outcomes include incidence of delayed postpartum hemorrhage and secondary infection; transport to higher-level facility; use of uterotonic agents; blood transfusion; and maternal mortality for 42 days. A nested case-control analysis of women who experience acute severe postpartum hemorrhage, compared to women who do not, will identify socioeconomic, behavioral, cultural, and systems factors associated with postpartum hemorrhage. For purposes of this study, acute PPH is defined as blood loss equal to or greater than 500 ml within 2 hours of delivery and acute severe PPH as blood loss equal to or greater than 1000 ml within 2 hours of delivery.

The sample size was based on a decrease of 50% PPH in the treated versus the control group; 20% rate of non-compliance, power of 96%, and a two-tailed type I error of 0.05

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: RCT of Misoprostol for Postpartum Hemorrhage in India
Study Start Date : September 2002
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery

Secondary Outcome Measures :
  1. Incidence of delayed postpartum hemorrhage and secondary infection (lower abdominal pain, fever and foul discharge)
  2. Transport to higher-level medical facility
  3. Use of uterotonic agents
  4. Blood transfusion
  5. Surgical intervention including curettage, vacuum aspiration for retained placental tissue or hysterectomy
  6. Maternal mortality for 42 days

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Gestational age equal to or greater than 28 weeks pregnant
  • Planning to deliver at home or at a sub-center in the Belgaum District, Karnataka India
  • Anticipating a spontaneous vaginal delivery
  • Ability and willingness to provide informed consent

Exclusion Criteria:

  • Previous caesarian section
  • Scheduled for caesarian section
  • Hemoglobin level less than 8 Gms%
  • Episodes of antepartum bleeding during the current pregnancy
  • Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic
  • In active labor and not previously screened, recruited, and consented
  • Absence of fetal heart sounds
  • Multiple pregnancy
  • Known history of bronchial asthma
  • Prior enrollment in this study during a previous pregnancy
  • History of complications (ante/postpartum hemorrhage/retained placenta/ acute inversion of uterus) during a previous pregnancy
  • High risk conditions including: diabetes, cardiac ailments, seizures, placenta previa or anticipated breech delivery.
  • Receiving injectable medicine at time of delivery
Contacts and Locations

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): NCT00097123

KLE Society's Jawaharlal Nehru Medical College
Belgaum, Karnataka, India, 590 010
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of Missouri-Columbia
Jawaharlal Nehru Medical College
Principal Investigator: Richard J Derman, M.D. University of Missouri-Columbia
More Information

Additional Information:
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00097123     History of Changes
Other Study ID Numbers: GN 08
U01HD042372 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2004    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by NICHD Global Network for Women's and Children's Health:
Acute postpartum hemorrhage
Global Network
Maternal and child health
Women's health

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