BMJ open · 2026
Feasibility of the OdonAssist device for assisted vaginal birth in a low-resource setting: ASSIST Ethiopia study protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Orsi Michele, Sall Fatimata Seydou, Fieni Stefania, Lihoreau Thomas, Nerich Virginie, Manenti Fabio, Bobbio Flavio Antonio, Taye Admasu, Merga Dereje, Cot Sophie, Mauny Frederic, Mottet Nicolas
Аннотация
INTRODUCTION: In sub-Saharan African countries, the population-based assisted vaginal birth (AVB) rate is approximately 1% as compared with 16% in Western Europe. Consequently, women experiencing prolonged labour often face limited access to prompt intervention, leading to maternal and perinatal complications or unnecessary caesarean sections (CS). The OdonAssist device has been developed to be safe, user-friendly and more acceptable than currently used AVB devices. We propose to conduct a study in Ethiopia to evaluate if the implementation of this innovation is feasible and may contribute to improving the access to AVB while reducing unnecessary CSs.
METHODS AND ANALYSIS: We designed a single-centre feasibility study at Saint Luke Catholic Hospital (Wolisso, Ethiopia), a secondary facility where AVB is routinely performed by midwives and health officers under gynaecologist supervision, reflecting the local health system. Following a quasi-experimental design, we will include three groups of 20 women: an intervention group (OdonAssist), a vacuum extraction cohort and a control group of second-stage CS (performed without a prior trial of instrumental birth). The primary objective is to assess the clinical and methodological feasibility of the OdonAssist by collecting preliminary data on safety, acceptability and quantifying potential efficacy relative to the current standard of care. An exploratory economic evaluation of direct healthcare costs will be performed.
ETHICS AND DISSEMINATION: Approved by the Oromia Regional Health Bureau. The study results will be published in peer-reviewed journals to inform future impact evaluations of the OdonAssist device in global maternal and perinatal health.
TRIAL REGISTRATION NUMBER: NCT06918509.
METHODS AND ANALYSIS: We designed a single-centre feasibility study at Saint Luke Catholic Hospital (Wolisso, Ethiopia), a secondary facility where AVB is routinely performed by midwives and health officers under gynaecologist supervision, reflecting the local health system. Following a quasi-experimental design, we will include three groups of 20 women: an intervention group (OdonAssist), a vacuum extraction cohort and a control group of second-stage CS (performed without a prior trial of instrumental birth). The primary objective is to assess the clinical and methodological feasibility of the OdonAssist by collecting preliminary data on safety, acceptability and quantifying potential efficacy relative to the current standard of care. An exploratory economic evaluation of direct healthcare costs will be performed.
ETHICS AND DISSEMINATION: Approved by the Oromia Regional Health Bureau. The study results will be published in peer-reviewed journals to inform future impact evaluations of the OdonAssist device in global maternal and perinatal health.
TRIAL REGISTRATION NUMBER: NCT06918509.