Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana

The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108289

Enrollment

1586

Registered

2010-04-21

Start date

2011-04-30

Completion date

2012-12-31

Last updated

2013-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

hemorrhage, uterotonic, oxytocin, blood loss, community, Ghana, randomized trial

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.

Interventions

OTHEROxytocin in Uniject

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
postpartum hemorrhage-3	after delivery of the baby	blood loss \>=500ml OR treatment dose of oxytocin provided OR referral for bleeding
postpartum hemorrhage-1	after delivery of baby	blood loss \>=500 ml after delivery of the baby, as measured through plastic calibrated drape
postpartum hemorrhage-2	after delivery of the baby	blood loss \>=500ml OR treatment dose of oxytocin provided

Secondary

Measure	Time frame	Description
neonatal death	first month of life	neonatal death is defined as death of a live born baby prior to completion of 28 days
need for neonatal resuscitation	0-6 hours after birth	—
Oxytocin use before delivery	labor and delivery	the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
stillbirth	labor/delivery	stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth

Other

Measure	Time frame	Description
Postpartum Hemorrhage >=1000ml	after delivery of the baby	1000ml or more blood is observed in the collection drape

Countries

Ghana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026