Open Access Study protocol

Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via UnijectTM by peripheral health care providers at home births: design of a community-based cluster-randomized trial

Cynthia K Stanton1*, Samuel Newton2, Luke C Mullany1, Patience Cofie3, Charlotte Tawiah Agyemang2, Edward Adiibokah2, Niamh Darcy4, Sadaf Khan5, Alice Levisay5, John Gyapong6, Deborah Armbruster7 and Seth Owusu-Agyei2

Author Affiliations

1 Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

2 Kintampo Health Research Centre, Kintampo, Ghana

3 PATH, Accra, Ghana

4 Research Triangle Institute, Research Triangle, North Carolina, USA

5 PATH, Seattle, Washington, USA

6 University of Ghana, formerly of Ghana Health Service, Health Research Unit, Accra, Ghana

7 United States Agency for International Development, formerly of PATH, Washington, DC, USA

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BMC Pregnancy and Childbirth 2012, 12:42  doi:10.1186/1471-2393-12-42

Published: 7 June 2012

Abstract

Background

Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana.

Methods

This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the UnijectTM injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1) blood loss ≥500 ml (BL); 2) treatment for bleeding (TX) and/or BL; 3) hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively.

Discussion

Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289.

Keywords:
Postpartum hemorrhage; oxytocin; uterotonics; randomized trial