{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Division of Obstetrics, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy"
      ],
      "name": "Michele Orsi"
    },
    {
      "affiliations": [
        "CHU Besançon, Inserm CIC 1431, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Fatimata Seydou Sall"
    },
    {
      "affiliations": [
        "Obstetrics and Gynecology Unit, Department of Medicine and Surgery, University of Parma, Parma, Emilia-Romagna, Italy"
      ],
      "name": "Stefania Fieni"
    },
    {
      "affiliations": [
        "CHU Besançon, Inserm CIC 1431, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France",
        "SINERGIES (UR4662), F-25000 Besançon, France, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France",
        "Tech4Health network (F-CRIN), Besançon, France"
      ],
      "name": "Thomas Lihoreau"
    },
    {
      "affiliations": [
        "CHU Besançon, INSERM, EFS-BFC, UMR 1098, Pôle Pharmacie, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Virginie Nerich"
    },
    {
      "affiliations": [
        "Doctors with Africa CUAMM, Padova, Italy"
      ],
      "name": "Fabio Manenti"
    },
    {
      "affiliations": [
        "Doctors with Africa CUAMM, Padova, Italy",
        "Saint Luke Catholic Hospital & College of Nursing and Midwifery, Wolisso, Ethiopia"
      ],
      "name": "Flavio Antonio Bobbio"
    },
    {
      "affiliations": [
        "Saint Luke Catholic Hospital & College of Nursing and Midwifery, Wolisso, Ethiopia"
      ],
      "name": "Admasu Taye"
    },
    {
      "affiliations": [
        "Saint Luke Catholic Hospital & College of Nursing and Midwifery, Wolisso, Ethiopia"
      ],
      "name": "Dereje Merga"
    },
    {
      "affiliations": [
        "CHU Besançon, Pôle Mère-Femme, Department of Obstetrics and Gynecology, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Sophie Cot"
    },
    {
      "affiliations": [
        "CNRS, Chrono-environnement (UMR 6249), Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France",
        "CHU Besançon, uMETh, Inserm CIC 1431, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Frederic Mauny"
    },
    {
      "affiliations": [
        "CHU Besançon, Inserm CIC 1431, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France",
        "SINERGIES (UR4662), F-25000 Besançon, France, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France",
        "CHU Besançon, Pôle Mère-Femme, Department of Obstetrics and Gynecology, Université Marie et Louis Pasteur, Besançon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Nicolas Mottet"
    }
  ],
  "title": "Feasibility of the OdonAssist device for assisted vaginal birth in a low-resource setting: ASSIST Ethiopia study protocol",
  "uid": "36b7f127-4645-5a92-99cb-64936ff1830d"
}