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

This study was done to test the safety and effectiveness of the use of trained Ghana Health Service (GHS) community health officers (CHOs) in administering one of the 13 UN Commission's life-saving commodities for women and children, namely oxytocin (10 intravenous units - IU) for prevention of postpartum haemorrhage (PPH), the leading cause of maternal death in low-income countries. Administration of oxcytocin was usually restricted to medically trained staff in health facilities; however, there is a need for its use by those attending home births in economically poor, rural communities where emergent transport to a health facility may not be possible. "The World Health Organization (WHO) recommends that in situations where women give birth without the assistance of a trained midwife, priority should be given to preventing PPH because access to emergency services may be limited."

"Expanding provision of oxytocin to peripheral settings raises three main concerns: (1) providers may not be skilled in giving injections, (2) heat exposure may compromise drug integrity/potency, and (3) administration prior to delivery of the baby (i.e., for induction and/or augmentation) outside a fully qualified facility increases risk to mother and baby....This study is designed as a cluster-randomized community-based trial in which Ghana Health Service (GHS) Community Health Officers (CHOs) are randomized into one of two study arms determining the care that CHOs provide to enrolled women during their home-based deliveries. For the purposes of this trial, all deliveries assisted by an individual CHO constitute a cluster. The trial is designed to determine if intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a CHO will reduce the risk of PPH by 50 % relative to deliveries attended by a CHO who does not provide the prophylactic intervention. This is not, however, a drug efficacy trial. The trial is designed to assess the mode of service delivery."

In four rural districts of Ghana, 69 field workers, with at least senior-high school education and resident in the communities for which they are responsible, worked with this study. There were nine field supervisors. "The field workers were provided with bicycles and the supervisors were provided with motorcycles to facilitate movement within their areas of work. All field staff participated in a three-day training prior to the start of the study." Kintampo Health Research Centre (KHRC) participated with researchers to design the study, particularly regarding the involvement of GHS CHOs as the agents to administer the study intervention. "CHO services include childhood vaccination, antenatal and postnatal care, family planning outreach, emergency deliveries, and referral for complications during pregnancy and delivery." CHOs had previously been trained to administer tablets of treatment for PPH but had not previously been trained or tasked with injectable PPH treatment until this training occurred.

"The study facilitated the placement of CHOs into communities in study districts where there were no CHOs and provided resources to improve CHO compounds where these were inadequate. Prior to the start of the study, all CHOs completed a five-day training course and were required to pass a competency-based examination specific to their cluster allocation. Throughout the course of the study, CHOs are provided with some allowance to purchase credit for their mobile phones as well as basic comfort items such as solar lamps and beds. The compounds are also provided with basic hospital equipment such as examination couches and cupboards for storage of medical supplies as a contribution to the expansion of the CHPS initiative. "

An Argentine pharmaceutical company provided the oxytocin in Uniject™ injection devices, which then entered the cold chain of the public health system. "[C]ommunity meetings were held with GHS authorities in various communities, opinion leaders, chiefs, and community members regarding the objectives of the study. KHRC field workers then began identifying on a weekly basis all households with a pregnant woman within their allotted communities." CHO and field workers worked together to collect birth data when a consenting woman called for their presence at a home birth, but neither attended the patient as the primary delivery attendant. In the designated sections of randomisation, CHOs delivered the injectable medication. Blood loss was measured as an indicator as were safety outcomes.

Results were published in October 2013 "Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial" of PLOS Medicine. The trial provided evidence that "administration of intramuscular prophylactic oxytocin in Uniject by peripheral health care providers without midwifery skills can effectively decrease the risk of PPH at home births under research conditions. Furthermore, none of the secondary outcomes reflecting safety suggested that this intervention was unsafe." The trial raised questions of cost and advocacy for worldwide availability, of who might be allowed to administer doses and whether vaccinators, for example, trained in injection, might be administrators, and of the relative uses of oxytocin and another PPH prevention commodity misoprostol - "[w]here and under what circumstances can each of these proven effective drugs be used?"