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The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy

NCT04169035 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-03-05

No results posted yet for this study

Summary

Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.

Conditions

  • Pregnant Woman

Interventions

DEVICE

The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.

The BD Odon DeviceTM works by placing a cuff of air attached to a plastic sleeve, around the baby's head. The doctor then gently pulls on this sleeve and air cuff to assist the birth of the baby.

PROCEDURE

forceps or ventouse

The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth. Forceps is a metal instrument with two handles used to encircle a baby's head and assist in birth. Ventouse is a device used to help a baby be born by putting it over the baby's head and using suction (= removing air) to pull the baby out of the mother's body.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2021-12-31
Completion
2022-06-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169035 on ClinicalTrials.gov