NCT00120237

Brief Summary

This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.

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 Jul 2005

Typical duration 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

July 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

3 years

First QC Date

July 7, 2005

Last Update Submit

March 17, 2009

Conditions

Postpartum HemorrhageAnemia

Keywords

Postpartum hemorrhageMisoprostolMaternal morbidityDeveloping countriesTraditional birth attendants

Outcome Measures

Primary Outcomes (2)

  • Postpartum hemorrhage (blood loss >or= 500 mL)

    Measured at 1 hour postpartum or until active bleeding has stopped

  • Drop in hemoglobin > 2 g/dL from pre to post-delivery

    Hemoblobin (Hb) level measured 3-5 days after delivery

Secondary Outcomes (4)

  • Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)

    Blood loss measured at 1 hr postpartum or until active bleeding stopped

  • Mean blood loss

    blood loss measured at 1 hr postpartum or until active bleeding stopped

  • Side effects experienced among recently delivered mothers

    Interviews conducted 1 day post-delivery

  • Anemia (<9 g/dL and <11 g/dL)

    Postpartum hemoglobin assessed 3 days post-delivery

Interventions

MisoprostolDRUG

600 mcg oral misoprostol administered during third stage of labor

Eligibility Criteria

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

You may qualify if:

  • Pregnant women in general good health, home delivery
  • Must live in one of 78 study villages

You may not qualify if:

  • Hypertension
  • Non-cephalic presentation
  • Polyhydramnios
  • Previous cesarean section
  • Suspected multiple pregnancy
  • Suspected still birth
  • Antepartum hemorrhage
  • Previous complication in 3rd trimester
  • Anemia of \<8 g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home delivery setting

Chitral, Chitral District, Pakistan

Location

Related Links

MeSH Terms

Conditions

Postpartum HemorrhageAnemia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gijs Walraven, MD

    Aga Khan Health Services

    PRINCIPAL INVESTIGATOR

  • Juanita Hatcher, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

  • Naushaba Mobeen, MD

    Aga Khan University

    STUDY DIRECTOR

  • Jennifer Blum, MPH

    Gynuity Health Projects

    STUDY DIRECTOR

  • Zafar Ahmad, MD

    Aga Khan Health Services

    STUDY DIRECTOR

  • Nadeem Zuberi, MD

    Aga Khan University

    STUDY DIRECTOR

  • Jill Durocher

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 15, 2005

Study Start

July 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

PA(1)