Cynthia Stanton and colleagues conducted a cluster-randomized controlled trial in rural Ghana to assess whether oxytocin given by injection by community health officers at home births was a feasible and safe option in preventing postpartum hemorrhage. Please see later in the article for the Editors' Summary

ObjectiveThe study analysed the effect of Information, Education, and Communication (IEC) campaign activities on the adoption of a community-based health insurance (CHI) scheme in Nouna, Burkina Faso. It also identified the factors that enhanced or limited the campaign's effectiveness.DesignComplementary data collection approaches were used. A survey was conducted with 250 randomly selected household heads, followed by in-depth interviews with 22 purposively selected community leaders, group discussions with the project management team, and field observations. Bivariate analysis and multivariate logistic regression models were used to assess the association between household exposure to campaign and acquisition of knowledge as well as household exposure to campaign and enrolment.ResultsThe IEC campaign had a positive effect on households’ knowledge about the CHI and to a lesser extent on household enrolment in the scheme. The effectiveness of the IEC strategy was mainly influenced by: (1) frequent and consistent IEC messages from multiple media channels (mass and interpersonal channels), including the radio, a mobile information van, and CHI team, and (2) community heads’ participation in the CHI scheme promotion. Education was the only significantly influential socio-demographic determinant of knowledge and enrolment among household heads. The relatively low effects of the IEC campaign on CHI enrolment are indicative of other important IEC mediating factors, which should be taken into account in future CHI campaign evaluation.ConclusionThe study concludes that an IEC campaign is crucial to improving the understanding of the CHI scheme concept, which is an enabler to enrolment, and should be integrated into scheme designs and evaluations.

ObjectivesGiven use of uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent uterotonics is indisputable. This study evaluated access to and potency of injectable uterotonics in Ghana.DesignStudy design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board.SettingThe study was conducted in three contrasting districts in Ghana.Outcome measureThe per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine.Results69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively.ConclusionsThe quality of injectable uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.

BackgroundHemorrhage 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.MethodsThis 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.DiscussionResults 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.

Oxytocin-in-Uniject devices could be stored 30 to 40 days without refrigeration under typical field conditions, with wastage levels below 10%, based on simulation studies.