ASSISTEthiopiaOdonAssist Device for Assisted Vaginal Birth in Ethiopia
OdonAssistTM
Other Study
Summary
Study start date: April 1, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating a new device called OdonAssist™ for helping with vaginal births. Traditionally, devices like forceps or vacuum extractors are used in complicated deliveries, but they can be difficult to use and may cause harm to mothers and babies if not handled properly. OdonAssist™, invented by an Argentinian car mechanic, is designed to be safer and easier to use. It works by inflating a soft air chamber around the baby's head, which helps to gently guide the baby out during birth. This study is being conducted at Saint Luke's Hospital in Wolisso, Ethiopia, to see if this new device can be effectively and safely used in a low-income setting, and whether it is more acceptable to both mothers and healthcare workers compared to traditional methods. Participants in this study will experience births assisted by the OdonAssist™ device, and researchers will collect data on how safe and effective the device is. They will compare these results with those from traditional methods like vacuum extractors and cesarean sections. The study also aims to assess the cost of using the OdonAssist™ compared to other methods. The device is single-use and ready to use, eliminating the need for maintenance. The goal is to improve access to safer childbirth methods and reduce complications for both mothers and babies, especially in regions where traditional assisted birth methods are less available or harder to use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location