Status:
RECRUITING
ASSIST Ethiopia: Feasibility Clinical Investigation of the Odonassist™ Medical Device
Lead Sponsor:
Doctors with Africa - CUAMM
Collaborating Sponsors:
Centre Hospitalier Universitaire de Besançon
St. Luke Catholic Hospital, Wolisso, Ethiopia
Conditions:
Instrumental Delivery
Medical Device
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The Innovation The OdonAssist™ is a medical device for assisted vaginal delivery (AVD), that is defined by the need of additional procedure to facilitate childbirth in order to reduce foetal-maternal ...
Detailed Description
INTRODUCTION The OdonAssist™ inflatable device for assisted vaginal birth (AVB), is a frugal innovation from the southern hemisphere and an unconventional environment as it was invented by an Argenti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06918509
Start Date
April 1 2025
End Date
March 1 2026
Last Update
December 30 2025
Active Locations (1)
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1
St. Luke Catholic Hospital
Waliso, Ethiopia