NCT01487278

Brief Summary

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

First QC Date

December 5, 2011

Last Update Submit

January 8, 2014

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhagepreventionmisoprostolUnijectoxytocin

Outcome Measures

Primary Outcomes (1)

  • Mean change in hemoglobin

    To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.

    during 3rd trimester and 1-3 days postpartum

Secondary Outcomes (6)

  • occurrence and management of side effects

    1 hour postpartum

  • correct timing of drug administration

    collected immediately following birth, verified 1-3 days postpartum

  • change in hemoglobin ≥ 2 g/dL

    during third trimester and 1-3 days postpartum

  • additional interventions

    during birth and 1-3 days postpartum

  • referrals

    1-3 days postpartum

  • +1 more secondary outcomes

Study Arms (2)

Misoprostol

EXPERIMENTAL

600 mcg oral misoprostol administered during the third stage of labor

Drug: misprostol

UnijectTM

EXPERIMENTAL

10 IU oxytocin delivered IM with UnijectTM during he third stage of labor

Device: UnijectTM

Interventions

misprostolDRUG

600 mcg misoprostol oral

Also known as: Cytotec
Misoprostol
UnijectTMDEVICE

10 IU oxytocin delivered intramuscularly with UnijectTM

UnijectTM

Eligibility Criteria

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

You may qualify if:

  • women delivering at home with a trained study provider who are able to provide informed consent

You may not qualify if:

  • women with known contraindications to prostaglandins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villages in Mopti

Mopti, Mali

Location

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

  • Ayisha R Diop, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Laura J Frye, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Yacouba Kone, M.D

    The Aga Khan Foundation

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

MA(1)