RCT of Misoprostol for Postpartum Hemorrhage in India

Pregnancy Clinical Trial

Official title:

RCT of Misoprostol for Postpartum Hemorrhage in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097123
• Other study ID #: GN 08
• Secondary ID: U01HD042372
• Status: Completed
• Phase: N/A
• First received: November 17, 2004
• Last updated: July 29, 2014
• Start date: September 2002
• Est. completion date: December 2005

Study information

• Verified date: July 2014
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Pregnancy

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
India	KLE Society's Jawaharlal Nehru Medical College	Belgaum	Karnataka

Sponsors (10)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health	Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, Jawaharlal Nehru Medical College, John E. Fogarty International Center (FIC), National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), RTI International, University of Missouri-Columbia

Country where clinical trial is conducted

India, 

References & Publications (1)

Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, Patted SS, Patel A, Edlavitch SA, Hartwell T, Chakraborty H, Moss N. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute postpartum hemorrhage: blood loss = 500 ml within two hours of delivery
Secondary	Incidence of delayed postpartum hemorrhage and secondary infection (lower abdominal pain, fever and foul discharge)
Secondary	Transport to higher-level medical facility
Secondary	Use of uterotonic agents
Secondary	Blood transfusion
Secondary	Surgical intervention including curettage, vacuum aspiration for retained placental tissue or hysterectomy
Secondary	Maternal mortality for 42 days

External Links

•   K.L.E. Society's Jawaharlal Nehru Medical College
•   Research Triangle Institute International
•   Website for the Global Network for Women's and Children's Health Research