Two workers inspecting Uniject devices filled with oxytocin

Uniject devices filled with oxytocin can help treat and prevent postpartum hemorrhage.

This web page is a resource for countries and programs considering the introduction of oxytocin in the Uniject® device (Uniject). Included in these resources are some essential pieces of information for planning and decision-making:

The easy-to-use, injection-ready format of Uniject ensures an accurate dose of oxytocin in a nonreusable, sterile device with minimal preparation and minimum waste. The features and benefits of oxytocin in Uniject will help programs launch innovative approaches to expand prevention and treatment of postpartum hemorrhage such as:

  • Administration by skilled midwives, auxiliary nurses, or other trained lay providers.
  • Use in areas of limited health facility infrastructure and/or health worker shortages.
  • Overcoming acceptability concerns, including fear of injections, and safety concerns, regarding reuse of needles.

These benefits can improve the ability of health workers to administer oxytocin in hospital facilities as well as during emergencies or in remote locations.

Policy and planning

WHO Statement regarding the use of misoprostol for postpartum haemorrhage prevention and treatment
WHO, 2009
This statement explains the current WHO position regarding the use of misoprostol for the prevention of postpartum hemorrhage.

Management of the Third Stage of Labor to Prevent Postpartum Hemorrhage: Joint Statement
ICM and FIGO, 2004
This statement provides recommendations on programming as well as specific interventions and procedures for the prevention of PPH. The International Federation for Obstetrics and Gynecology (FIGO) and the International Confederation of Midwives (ICM) are key partners in global efforts to reduce maternal death and disability in the world. Their mission statements share a common commitment in promoting the health, human rights, and well-being of all women, especially those at greatest risk of death and disability associated with childbearing.

Prevention and Treatment of Postpartum Hemorrhage: New Advances for Low Resource Settings: Joint Statement
ICM and FIGO, 2006
This statement summarizes the current status of prevention and treatment of PPH in low-resource settings and provides recommendations for improving the continuum of care. Both ICM and FIGO endorse international recommendations that emphasize the provision of skilled birth attendants and improved obstetric services as central to efforts to reduce maternal and neonatal mortality.

Recommendations on the Prevention of Postpartum Hemorrhage: A Summary of the Results from a WHO Consultation
WHO, 2006
The World Health Organization (WHO) held a Technical Consultation in Geneva to discuss the various issues related to the prevention of PPH and to develop recommendations. This document highlights key recommendations from the report.

Managing Complications in Pregnancy and Childbirth: A Guide for Midwives and Doctors
WHO, 2007
The chapter entitled Vaginal Bleeding After Childbirth in this guide provides WHO guidance on managing vaginal bleeding after childbirth, including recommendations for oxytocin administration and dosing.

Technical resources

Uniject

HealthTech Historical Profile: The Uniject Device
PATH, 2005
This document provides an overview of PATH’s development and advancement of the Uniject device.

The Radically Simple Uniject Device
PATH, 2003
This four-page brochure tells the story of the Uniject device—how it grew from a concept to an easy-to-use, all-in-one injection device that will be used to vaccinate every newborn in Indonesia against hepatitis B and to help eliminate maternal and neonatal tetanus globally. The publication covers the development, evaluation, licensing, production, and design and function of the Uniject device. Photographs and a timeline of Uniject’s history are included.

Introducing TT Uniject in Maternal and Neonatal Tetanus Elimination
PATH, 2003
This document provides materials to assist health workers and program managers in the introduction, training, and proper use of the tetanus toxoid vaccine in Uniject.

Oxytocin in Uniject

Introducing Oxytocin in the Uniject Device: An Overview for Decision-Makers
PATH, 2008
This overview has been developed for program planners considering introduction and/or expansion of the use of oxytocin, in particular oxytocin packaged in the Uniject device, to reduce the incidence of PPH as a component of their maternal and child health programming. Administering oxytocin is just one component of active management of the third stage of labor. Available in English and Spanish.

A HealthTech Reference List: Key References and Resources for the Introduction of Oxytocin in the Uniject™ Device
PATH, 2008
This compilation contains key references and resources to aid program planners in the introduction of oxytocin in Uniject.

Time-Temperature Indicators: Increasing the Flexibility of Transport, Storage, and Use of Oxytocin in the Uniject™ Device
PATH, 2009
This document describes how the addition of a time-temperature indicator, a small sticker indicating how much heat the product has been exposed to, can add flexibility to the transport and storage of oxytocin in Uniject while minimizing the waste of good product and the inadvertent use of heat-spoiled product.

In development. Please check back soon.

Field evaluations

Reducing Postpartum Hemorrhage in Thanh Hoa, Viet Nam: Assessing the Role of Active Management of Third Stage of Labor and of Oxytocin in Ampoules and Uniject Devices
PATH and the Reproductive Health Department of the Vietnam Ministry of Health, 2003
This report details findings from a study undertaken in Vietnam to evaluate the acceptability and ease of use of oxytocin in Uniject by midwives at primary- and secondary-level facilities. It also includes analyses of the effectiveness of active management of the third stage of labor (AMTSL) in reducing rates of PPH and the need for treatment of hemorrhage, the cost-effectiveness of routine delivery of AMTSL, and the relative costs of using oxytocin in ampoules or in Uniject.

Pilot Use of Oxytocin in a Uniject™ Device for AMTSL in Mali
PATH, 2008
This describes use of the Uniject device prefilled with 10 IU of oxytocin for actively managing the third stage of labor in selected health centers in Mali. This study was necessary because, while the Uniject device had previously been used for tetanus toxoid vaccination in Mali, the Ministry of Health lacked documentation of the safety and feasibility of using the device to deliver oxytocin for active management of the third stage of labor.

Download/view file (1,209 KB PDF) from POPPHI website.

Training

Using Oxytocin in the Uniject Device (10IU in 1 ml)
PATH, 2009
This job aid provides written and pictoral instruction for health workers for the administration of oxytocin in Uniject. Available in English and Spanish.

Reading Time-Temperature Indicators With the Uniject® Device
PATH, 2009
This job aid illustrates how to read time-temperature indicators with the Uniject device. Available in English and Spanish.

Reading Time-Temperature Indicators With the Uniject® Device: Worksheet
PATH, 2009
This worksheet can be used during trainings to help health workers learn how to read time-temperature indicators on the Uniject device. Available in English and Spanish.

Online resources

Prevention of Postpartum Hemorrhage Initiative (POPPHI)
POPPHI is part of the United States Agency for International Development’s (USAID’s) broader Special Initiative to reduce PPH, the single most important cause of maternal deaths worldwide, through expanded use of active management of the third stage of labor.
Visit the POPPHI website.

World Health Organization (WHO)
WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. The WHO website contains a wealth of information on PPH and active management of the third stage of labor including job aids, research reports, and recommended practices. Many of these documents are managed by the WHO Department of Making Pregnancy Safer.

Visit WHO’s Making Pregnancy Safer web page.

Availability

After many years of technical development and preliminary field evaluation, oxytocin in Uniject has received its first regulatory approval for commercial marketing as a pharmaceutical product. In October 2008 the Argentine pharmaceutical manufacturer Instituto Biologio Argentino (BIOL) received approval to market its oxytocin in the Uniject prefilled injection device in Argentina from the Argentine drug regulatory authority (ANMAT). BIOL expects to begin commercial sales in Argentina during spring 2009 and is initiating the registration process is several additional countries.

Several pilot activities introducing oxytocin in Uniject are underway or planned for 2009. Introduction activities are being implemented in Honduras, Guatemala, and South Africa with interest being expressed in a number of other countries.

Now that oxytocin in Uniject moving from development into country registration and manufacturing scale-up, more programs can now begin planning for evaluation and/or introduction activities.

PATH, through our collaboration with BIOL, may be able to facilitate initial supply of oxytocin in Uniject to support country and program evaluation.

Acknowledgements

PATH’s work on oxytocin in Uniject is supported by USAID through the HealthTech and POPPHI projects, by the Bill & Melinda Gates Foundation through the Oxytocin Challenge: Maximizing Safe Use Project, and others.

Uniject is a registered trademark of BD.