NCT01462422

Brief Summary

This study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of PPH. The study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of PPH. This cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of PPH care using misoprostol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,032

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

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

First Submitted

Initial submission to the registry

October 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

2.2 years

First QC Date

October 27, 2011

Last Update Submit

June 13, 2014

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhagePreventionMisoprostolDeveloping countriesNurse midwife

Outcome Measures

Primary Outcomes (1)

  • Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL

    A 20% rate of post delivery Hb ≤7.8 gm/dL in the study arm with women receiving selective administration of 800 mcg sublingual misoprostol is non-inferior to a 13% rate of post delivery Hb ≤ 7.8 gm/dL in the study arm with women receiving universal 600 mcg oral misoprostol prophylaxis.

    72 hours (plus or minus 8 hours) after delivery

Secondary Outcomes (9)

  • Rate of transfer to referral facilities for PPH

    within 72 hours (plus or minus 8 hours) after delivery

  • Rate of PPH

    within 1 hour after delivery

  • Rate of severe PPH

    within 1 hour after delivery

  • Rate of adverse events

    Within 72 hours (plus or minus 8 hours) after delivery

  • Mean blood loss

    1 hour after delivery

  • +4 more secondary outcomes

Study Arms (2)

Primary prevention

OTHER
Drug: Misoprostol

Secondary Prevention

OTHER
Drug: Misoprostol

Interventions

MisoprostolDRUG

Selective administration of 800 mcg sublingual misoprostol to women with at least 350 mL blood loss within 1 hour following delivery

Secondary Prevention

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • delivering at home or sub-center with an auxilliary nurse midwife (ANM)
  • able and willing to provide informed consent
  • meeting Ministry of Health Guidelines for home or sub-center delivery

You may not qualify if:

  • \. high-risk pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deliveries at health sub-centers and homes

Vijayapura, Karnataka, 586103, India

Location

Related Publications (1)

  • Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

    PMID: 33232518DERIVED

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

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Sheila Raghavan, MSc

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Stacie Gellar, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

  • Suellen Miller, PhD, CNM

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Shivaprasad S Goudar, MD, MHPE

    Jawaharlal Nehru Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2011

First Posted

October 31, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

IN(1)