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New Birth-Assist device tested in rural ethiopia

NCT ID NCT06918509

Knowledge-focused Sponsor: Doctors with Africa - CUAMM Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new medical device called OdonAssist™ for helping with difficult births in a rural Ethiopian hospital. Twenty women who needed assistance during labor used the device, and researchers checked how well it worked, how safe it was, and how acceptable it felt to mothers and healthcare workers. The goal was to see if this device could be a better option than traditional tools like forceps or vacuum, especially in low-resource settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OdonAssist™ medical device
What this could lead to
If successful, this device could provide a safer, simpler alternative to forceps or vacuum for assisted childbirth, especially in low-resource settings.
What could go wrong
This is a small feasibility study with only 20 participants, so results may not apply broadly. The device is still experimental and not yet proven effective or safe in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Apr 2025

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acceptability study Feasibility study Instrumental delivery Medical device Pregnancy

Contacts and locations

Locations

  • St. Luke Catholic Hospital

    Waliso, Ethiopia

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