Scaling up Ghana's national newborn care initiative: integrating 'helping babies breathe' (HBB), 'essential care for every baby' (ECEB), and newborn 'infection prevention' (IP) trainings.

BACKGROUND: Responding to stagnating neonatal mortality rates in Ghana, a five-year collaboration called Making Every Baby Count Initiative (MEBCI) was undertaken to improve the quality of newborn care provided around the time of birth. A multi-pronged approach was used to build health worker (HW) capacity in resuscitation, essential newborn care, and infection prevention using a curriculum built on the American Academy of Pediatric's (AAP) Helping Babies Breathe (HBB) and Essential Care for Every Baby (ECEB) modules with an added section on infection prevention (IP). METHODS: MEBCI used a training of trainer's approach to train 3688 health workers from district-level facilities in four regions in Ghana between June 2015 and July 2017. Prior to training, HWs familiarized themselves with the learning materials. Concurrently, MEBCI worked to improve enabling environments that would sustain the increased capacity of trained health workers. Knowledge and skills gained were tested using AAP's Knowledge checklist and validated single-scenario Objective Structured Clinical Examinations (OSCEs) tools. FINDINGS: Majority of HWs trained were midwives (58.8%) and came from district-level hospitals (88.4%). Most HWs passed the HBB OSCE (99.9%, 3436/3440). Age of doctors was negatively associated with HBB scores (r = - 0.16, p = 0.0312). Similarly, older midwives had lower HBB scores (r = - 0.33, p value < 0.001). Initiating ventilation within the Golden Minute was challenging for HWs (78.5% passed) across all regions. Overall, the pass rate for ECEB OSCEs was 99.9% in all regions. Classify newborn for further care and communicate plan to family were frequent challenges observed in Volta Region (69.5% and 72.0% pass rate respectively). HWs less than 40 years of age performed significantly better than health workers older than 40 years (p = 0.023). Age of only paediatricians was positively associated with ECEB scores (r = 0.77, p < 0.001) while age of midwives was negatively associated with ECEB scores (r = - 0.08, p < 0.001). CONCLUSION: MEBCI's integrated HBB-ECEB-IP training resulted in significant mastery of the clinical knowledge and skills of HWs. Harmonization and standardization of the course delivery by trainers and having a core team to ensure training fidelity are essential to maintaining high quality while scaling a program nationally. FUNDING: Children's Investment Fund Foundation (CIFF).

Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial.

BACKGROUND: Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births. METHODS AND FINDINGS: This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls. CONCLUSION: Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births. TRIAL REGISTRATION: ClinicalTrials.gov NCT01108289 Please see later in the article for the Editors' Summary.

Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study.

OBJECTIVES: Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. DESIGN: A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. SETTING: Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. PARTICIPANTS: Obstetric staff (n=451) working within participating facilities. INTERVENTION: PPH management training courses were conducted with obstetric staff. PRIMARY AND SECONDARY OUTCOME MEASURES: Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. RESULTS: All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. CONCLUSIONS: The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. TRIAL REGISTRATION NUMBERS: NCT04502173; NCT05340777.

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.

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 Uniject™ 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.

Evaluating a novel neonatal-care assessment tool among trained delivery attendants in a resource-limited setting.

OBJECTIVE: To validate a novel objective structured clinical examination (OSCE) tool for assessing neonatal care skills among delivery attendants trained as part of the Essential Care for Every Baby (ECEB) program and to assess ECEB training effectiveness. METHODS: Between August 1 and September 30, 2015, a cross-sectional study enrolled ECEB-trained healthcare providers who attended deliveries from the Brong Ahafo and Eastern regions of Ghana. Participants completed a previously developed 21-item OSCE tool that assessed neonatal-care competency. Participant performance was scored independently by regional trainers and national master trainers. The inter-rater scoring reliability was assessed using the Cohen kappa coefficient and performance was compared across participant characteristics. RESULTS: The study enrolled 57 trained delivery attendants from 12 district hospitals. Inter-rater agreement was perfect (kappa 1.00) or almost perfect (kappa 0.81-0.99) for nine OSCE items, substantial (kappa 0.61-0.80) or moderate (kappa 0.41-0.60) for 11 items, and fair (kappa 0.21-0.40) for one item. Differences in OSCE-item performance were recorded based on participants' regions, facility type, age, and education level (P<0.05). CONCLUSIONS: In a resource-limited setting, the OSCE tool demonstrated substantial reliability and ECEB-trained healthcare practitioners exhibited satisfactory performance. The OSCE tool could be useful in similar settings and could have potential for up-scaled use in assessing neonatal-management skills.

Cumulative effects of heat exposure and storage conditions of Oxytocin-in-Uniject in rural Ghana: implications for scale up.

OBJECTIVE: Postpartum hemorrhage can be reduced substantially in home deliveries attended by community-based workers by using Oxytocin-in-Uniject (OIU) devices affixed with temperature-time indicators. We characterized the distribution of time to discard of these devices when stored under normal field conditions in Ghana. METHODS: Two drug storage simulation studies were conducted in rural Ghana in 2011 and 2012. Devices were transported under refrigeration from manufacture (Argentina) to storage at the study site. Twenty-three field workers each stored at home (unrefrigerated) 25 OIU devices and monitored them daily to record: (1) time to transition from usable to unusable, and (2) continuous digital ambient temperature to determine heat exposure over the simulation period. Time to discard was estimated and compared with mean kinetic temperature exposure of the devices during the shipment and storage phases and with characteristics of the storage locations using Weibull regression models. We used the time to discard distributions in a Monte Carlo simulation to estimate wastage rates in a hypothetical program setting. RESULTS: Time for shipment and transfer to long-term refrigerated storage and mean kinetic temperature during the shipment phase was 8.6 days/10.3°C and 13.4 days/12.1°C, for the first and second simulation studies, respectively. Median (range) time to discard when stored under field conditions (unrefrigerated) was 43 (6 to 59) days and 33 (14 to 50) days, respectively. Mean time to discard was 10.0 days shorter in the second simulation, during which mean kinetic temperature exposure was 3.9°C higher. Simulating a monthly distribution system and assuming typical usage, predicted wastage of product was less than 10%. CONCLUSION: The time to discard of devices was highly sensitive to small changes in temperature exposure. Under field conditions typical in rural Ghana, OIU packages will have a half-life of approximately 30 to 40 days based on the temperature monitor used during the study. Program managers will need to carefully consider variations in both ambient temperature and rate of use to allocate the appropriate supply level that will maximize coverage and minimize stock loss.

Effects of information, education, and communication campaign on a community-based health insurance scheme in Burkina Faso.

OBJECTIVE: The 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. DESIGN: Complementary 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. RESULTS: The 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. CONCLUSION: The 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.

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.

OBJECTIVES: Given 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. DESIGN: Study 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. SETTING: The study was conducted in three contrasting districts in Ghana. OUTCOME MEASURE: The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. RESULTS: 69 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. CONCLUSIONS: The 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.