CompletedNot Applicable

ASSIST Ethiopia: Feasibility Clinical Investigation of the Odonassist™ Medical Device

Ethiopia20 participantsStarted 2025-04-01

Plain-language summary

The Innovation The OdonAssist™ is a medical device for assisted vaginal delivery (AVD), that is defined by the need of additional procedure to facilitate childbirth in order to reduce foetal-maternal risks. Increasing access to AVD has been identified by the World Health Organization (WHO) as one of the priorities for improving maternal health globally. The OdonAssist™ is a frugal innovation born in the southern hemisphere in an unconventional environment. It was invented by an Argentinian mechanic, Jorge Odon. Its potential to improve maternal and neonatal health is now recognised. It has been designed to be safe, simple to use and better accepted than current devices (forceps, suction cup). Two studies conducted in England and one in France have confirmed these characteristics and funding has recently been obtained for a randomised clinical investigation in five French hospitals. Project Rationale The present project aims to conduct a feasibility study at Saint Luke's Hospital in Wolisso, a poorly resourced hospital in rural Ethiopia, in order to test the device in a low-income country and assess its acceptability. In addition, with the aim of investigating the efficiency and budgetary impact of this new device, and considering the wider perspective of a future scale-up, data will be collected on its cost-effectiveness, in order to compare it with the reference interventions at local level (vacuum and caesarean section). Main research questions: 1. Is it feasible to introduce the OdonAssist™ (new intervention) at the hospital Saint Luke's in Ethiopia, in terms of preliminary data on safety, efficacy, acceptability by mothers and healthcare providers? 2. What are the estimated healthcare-related costs of the OdonAssist™ (new intervention) in comparison to traditional alternatives, that are vacuum-assisted delivery or cesarean section during the second stage of labor? Study population Participants will be assisted with the OdonAssist™ medical device in case they have provided informed consent and they present medical indication for AVD as per protocol. The study will also collect data on a nested cohort of women and babies delivered either by vacuum extractor or by second-stage cesarean section. The information gained from this study will be used to plan for future impact evaluation and cost utility studies relevant for the implementation and for the scaling up of the OdonAssist™ in low resource settings. The study site will be Saint Luke's Hospital, Wolisso, Oromia region, Ethiopia.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: Women will be able to participate in the ASSIST Ethiopia Study if all of the following apply at initial consent: * ≥18 years of age; * singleton pregnancy of at least 36 weeks' gestation, * negative antenatal screen for HIV and Hepatitis B, * in active labour and requiring an assisted vaginal birth for a clinical indication (as per local guidelines), * the vertex is 1 cm or more below the ischial spines and there is no obstetric indication for an alternative method of AVB. Exclusion Criteria: Women will not be able to take part in the ASSIST Ethiopia Study if: * the fetal vertex is at or above the ischial spines, * there is a diagnosis of a fetal skull abnormality (i.e. macrocephaly) or osteogenesis imperfecta, * there is a suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia), * there is an intrauterine fetal death in the current pregnancy, * the woman is sensitive to latex, * the woman is currently serving a prison sentence, * there is a fetal bradycardia which is on-going and has not recovered.

What they're measuring

Efficacy of delivery assistance with the OdonAssistTM medical device

Timeframe: From enrollment to 6 weeks postpartum

Trial details

NCT IDNCT06918509

SponsorDoctors with Africa - CUAMM

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31