NCT01108289

Brief Summary

This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

1.7 years

First QC Date

April 2, 2010

Last Update Submit

July 1, 2013

Conditions

Postpartum Hemorrhage

Keywords

hemorrhageuterotonicoxytocinblood losscommunityGhanarandomized trial

Outcome Measures

Primary Outcomes (3)

  • postpartum hemorrhage-1

    blood loss \>=500 ml after delivery of the baby, as measured through plastic calibrated drape

    after delivery of baby

  • postpartum hemorrhage-2

    blood loss \>=500ml OR treatment dose of oxytocin provided

    after delivery of the baby

  • postpartum hemorrhage-3

    blood loss \>=500ml OR treatment dose of oxytocin provided OR referral for bleeding

    after delivery of the baby

Secondary Outcomes (4)

  • Oxytocin use before delivery

    labor and delivery

  • stillbirth

    labor/delivery

  • neonatal death

    first month of life

  • need for neonatal resuscitation

    0-6 hours after birth

Other Outcomes (1)

  • Postpartum Hemorrhage >=1000ml

    after delivery of the baby

Study Arms (2)

Oxytocin in Uniject

EXPERIMENTAL

Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby

Other: Oxytocin in Uniject

PPH Treatment Only

NO INTERVENTION

Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject

Interventions

Oxytocin in UnijectOTHER

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Also known as: uterotonic, pitocin
Oxytocin in Uniject

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • home delivery
  • presence of Community Health Officer at time of delivery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kintampo Health Research Center

Kintampo, Brong Ahafo, Ghana

Location

Related Publications (2)

  • Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, Amenga-Etego S, Darcy N, Khan S, Armbruster D, Gyapong J, Owusu-Agyei S. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013 Oct;10(10):e1001524. doi: 10.1371/journal.pmed.1001524. Epub 2013 Oct 1.

    PMID: 24130463DERIVED

  • Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, Darcy N, Khan S, Levisay A, Gyapong J, Armbruster D, Owusu-Agyei S. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012 Jun 7;12:42. doi: 10.1186/1471-2393-12-42.

    PMID: 22676921DERIVED

MeSH Terms

Conditions

Postpartum HemorrhageHemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Cynthia Stanton, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • Sam Newton, MD, PhD

    Kintampo Health Research Center, Kintampo, Ghana

    PRINCIPAL INVESTIGATOR

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

April 2, 2010

First Posted

April 21, 2010

Study Start

April 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

GH(1)