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

Launched by DOCTORS WITH AFRICA - CUAMM · Mar 31, 2025

Keywords

ClinConnect Summary

The ASSIST Ethiopia trial is studying a new medical device called the OdonAssist™, which helps with assisted vaginal delivery (AVD) during childbirth. This device was created to make the delivery process safer and easier for both mothers and babies, especially in places with limited medical resources. The trial is taking place at Saint Luke's Hospital in Wolisso, Ethiopia, and aims to find out if the OdonAssist™ is safe, effective, and well-accepted by mothers and healthcare providers in a low-income setting. Researchers will also look at how much it costs to use this device compared to traditional methods like vacuum delivery or cesarean section.

To participate in this study, women must be at least 18 years old and in active labor, with a single baby that is at least 36 weeks along in the pregnancy. They should also have no major health issues that would prevent the use of this device. If eligible, participants can expect to receive assistance with the OdonAssist™ during their delivery, and their experiences will be used to help improve maternal health care in the future. This trial is not yet recruiting participants, but it is an important step toward better childbirth options in under-resourced areas.

Gender

FEMALE

Eligibility 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.