NCT00097123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

November 17, 2004

Last Update Submit

July 29, 2014

Conditions

Postpartum HemorrhagePregnancy

Keywords

Acute postpartum hemorrhagePPHMisoprostolGlobal NetworkUterotonicsIndiaMaternal and child healthInternationalWomen's health

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

MisoprostolDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KLE Society's Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590 010, India

Location

Related 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. 2006 Oct 7;368(9543):1248-53. doi: 10.1016/S0140-6736(06)69522-6.

    PMID: 17027730RESULT

Related Links

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Richard J Derman, M.D.

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2004

First Posted

November 18, 2004

Study Start

September 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

IN(1)