Trials / Unknown
UnknownNCT04169035
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Besancon · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-12-04
- Primary completion
- 2021-12-31
- Completion
- 2022-06-15
- First posted
- 2019-11-19
- Last updated
- 2021-03-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04169035. Inclusion in this directory is not an endorsement.