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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2022-06-15

Brief Summary

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

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Detailed Description

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Conditions

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Pregnant Woman

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Odon device

The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assiste vaginal birth. Odon trained practitioner available to assist the birth.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Forceps or ventouse

The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assisted vaginal birth.

The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth.

Group Type ACTIVE_COMPARATOR

forceps or ventouse

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The woman is ≥18 years of age
* The woman has a singleton pregnancy
* The pregnancy is ≥28+0 weeks' gestation
* There is a negative antenatal screen for HIV and Hepatitis B

* There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
* There is a known osteogenesis imperfecta affected pregnancy
* There is 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
* The woman lacks capacity to consent
* The woman has a lack of ability to read or understand French as this would preclude successful completion of questionnaires
* The woman has received intramuscular or intravenous opiates (i.e. pethidine or morphine) within the past 6 hours
* The woman is in established labour (≥ 4cm cervical dilatation) without regional analgesia in place

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes