Feasibility of the OdonAssist™ device for assisted vaginal delivery in Ethiopia
ASSIST Ethiopia: Feasibility Clinical Investigation of Assisted Vaginal Birth With the Odonassist™ Medical Device
This study is testing a new device called OdonAssist™ to see if it can make assisted vaginal delivery safer and easier for mothers in Ethiopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Doctors with Africa - CUAMM Academic / other |
| Locations | 1 site (Waliso) |
| Trial ID | NCT06918509 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of the OdonAssist™ medical device for assisted vaginal delivery in a low-income setting at St. Luke's Hospital in Wolisso, Ethiopia. The OdonAssist™ is designed to be a safer and more user-friendly alternative to traditional delivery instruments like forceps and vacuum extractors. The study will collect data on its effectiveness and cost compared to standard interventions, aiming to improve maternal and neonatal health outcomes. The project aligns with Ethiopia's health priorities and seeks to enhance access to assisted vaginal delivery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older, with a singleton pregnancy of at least 36 weeks in active labor requiring assisted vaginal birth.
Not a fit: Patients who may not benefit from this study include those with fetal vertex above the ischial spines or diagnosed with fetal abnormalities.
Why it matters
Potential benefit: If successful, this study could significantly improve maternal and neonatal health outcomes by providing a safer and more acceptable method for assisted vaginal delivery.
How similar studies have performed: Previous studies in France and the UK have shown promising results for the OdonAssist™ device, indicating its potential effectiveness and acceptability.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Waliso
- St. Luke Catholic Hospital — Waliso, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Flavio Bobbio, MD — Doctors with Africa - CUAMM
- Study coordinator: Michele Orsi, MD
- Email: m.orsi@cuamm.org; michele.3@hotmail.it
- Phone: +39 3384462339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.