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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnant Woman
• Intervention / Treatment: Device: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.; Procedure: forceps or ventouse

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louis BENAZET; Phone Number: +33 381 219 147; Email: lbenazet@chu-besancon.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU Besançon
    • Contact: Louis BENAZET
    • Principal Investigator: Nicolas Mottet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Exclusion Criteria:

• The woman does not fulfil all of the inclusion criteria listed
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of births successfully assisted with the BD Odon Device	Successful vaginal birth with the BD ODON DeviceTM: successful BD Odon assisted birth in the absence of maternal and neonatal serious adverse reactions	3 months after delivery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 15, 2022

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: P/2019/435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No