A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol.

BACKGROUND: A birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions. METHODS: This two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang'a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country. DISCUSSION: Ample evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings. TRIAL REGISTRATION: Trial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022.

Effectiveness of an Electronic Partogram: A Mixed-Method, Quasi-Experimental Study Among Skilled Birth Attendants in Kenya.

BACKGROUND: Timely identification and management of intrapartum complications could significantly reduce maternal deaths, intrapartum stillbirths, and newborn deaths due to hypoxia. The World Health Organization (WHO) identifies monitoring of labor using the paper partograph as a high-priority intervention for identifying abnormities in labor and fetal well-being. This article describes a mixed-method, quasi-experimental study to assess the effectiveness of an Android tablet-based electronic, labor clinical decision-support application (ePartogram) in limited-resource settings. METHODS: The study, conducted in Kenya from October 2016 to May 2017, allocated 12 hospitals and health centers to an intervention (ePartogram) or comparison (paper partograph) group. Skilled birth attendants (SBAs) in both groups received a 2-day refresher training in labor management and partograph use. The intervention group received an additional 1-day orientation on use and care of the Android-based ePartogram app. All outcomes except one compare post-ePartogram intervention versus paper partograph controls. The exception is outcome of early perinatal mortality pre- and post-ePartogram introduction in intervention sites compared to control sites. We used log binomial regression to analyze the primary outcome of the study, suboptimal fetal outcomes. We also analyzed for secondary outcomes (SBAs performing recommended actions), and conducted in-depth interviews with facility in-charges and SBAs to ascertain acceptability and adoptability of the ePartogram. RESULTS: We compared data from 842 clients in active labor using ePartograms with data from 1,042 clients monitored using a paper partograph. SBAs using ePartograms were more likely than those using paper partographs to take action to maintain normal labor, such as ambulation, feeding, and fluid intake, and to address abnormal measurements of fetal well-being (14.7% versus 5.3%, adjusted relative risk=4.00, 95% confidence interval [CI]=1.95-8.19). Use of the ePartogram was associated with a 56% (95% CI=27%-73%) lower likelihood of suboptimal fetal outcomes than the paper partograph. Users of the ePartogram were more likely to be compliant with routine labor observations. SBAs stated that the technology was easy to use but raised concerns about its use at high-volume sites. Further research is needed to evaluate costs and benefit and to incorporate recent WHO guidance on labor management. CONCLUSION: ePartogram use was associated with improvements in adherence to recommendations for routine labor care and a reduction in adverse fetal outcomes, with providers reporting adoptability without undue effort. Continued development of the ePartogram, including incorporating new clinical rules from the 2018 WHO recommendations on intrapartum care, will improve labor monitoring and quality care at all health system levels.

Contraceptive implant failures among women using antiretroviral therapy in western Kenya: a retrospective cohort study.

Background: Women living with HIV have the right to choose whether, when and how many children to have. Access to antiretroviral therapy (ART) and contraceptives, including implants, continues to increase due to a multitude of efforts. In Kenya, 4.8% of adults are living with HIV, and in 2017, 54% were receiving an efavirenz-based ART regimen. Meanwhile, 16.1% of all Kenyan married (and 10.4% of unmarried) women used implants. Studies have reported drug interactions leading to contraceptive failures among implant users on ART. This retrospective record review aimed to determine unintentional pregnancy rates among women 15-49 years of age, living with HIV and concurrently using implants and ART in western Kenya between 2011 and 2015. Methods: We reviewed charts of women with more than three months of concurrent implant and ART use. Implant failure was defined as implant removal due to pregnancy or birth after implant placement, but prior to scheduled removal date. The incidence of unintended pregnancy was calculated by woman-years at risk, assuming a constant rate. Results: Data from 1,152 charts were abstracted, resulting in 1,190 implant and ART combinations. We identified 115 pregnancies, yielding a pregnancy incidence rate of 6.32 (5.27-7.59), with 9.26 among ETG and 4.74 among LNG implant users, respectively. No pregnancies were recorded among women on non-NNRTI-based regimens, whereas pregnancy rates for efavirenz and nevirapine-containing regimens were similar, at 6.41 (4.70-8.73) and 6.44 (5.13-8.07), respectively. Conclusions: Our findings highlight the implications of drug interaction on women's choices for contraception.