Trial record 9 of 452 for:    NICHD + women's health

RCT of Misoprostol for Postpartum Hemorrhage in India

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Missouri-Columbia
Jawaharlal Nehru Medical College
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00097123
First received: November 17, 2004
Last updated: December 30, 2008
Last verified: December 2008
  Purpose

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 Intervention
Postpartum Hemorrhage
Pregnancy
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: RCT of Misoprostol for Postpartum Hemorrhage in India

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

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

Estimated Enrollment: 1600
Study Start Date: September 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097123

Locations
India
KLE Society's Jawaharlal Nehru Medical College
Belgaum, Karnataka, India, 590 010
Sponsors and Collaborators
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Missouri-Columbia
Jawaharlal Nehru Medical College
Investigators
Principal Investigator: Richard J Derman, M.D. University of Missouri-Columbia
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00097123     History of Changes
Other Study ID Numbers: GN 08, U01 HD042372
Study First Received: November 17, 2004
Last Updated: December 30, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Acute postpartum hemorrhage
PPH
Misoprostol
Global Network
Uterotonics
India
Maternal and child health
International
Women's health

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

ClinicalTrials.gov processed this record on April 23, 2014