NCT04169035

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

December 4, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

November 14, 2019

Last Update Submit

March 4, 2021

Conditions

Pregnant Woman

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Odon device

EXPERIMENTAL

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.

Forceps or ventouse

ACTIVE COMPARATOR

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

Interventions

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

Odon device
forceps or ventousePROCEDURE

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.

Forceps or ventouse

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Besancon

Besançon, France

RECRUITING

Related Publications (1)

  • Mottet N, Hotton E, Eckman-Lacroix A, Bourtembourg A, Metz JP, Cot S, Poitrey E, Delhomme L, Languerrand E, Nallet C, Lallemant M, Draycott T, Riethmuller D. Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study. Am J Obstet Gynecol. 2024 Mar;230(3S):S947-S958. doi: 10.1016/j.ajog.2023.05.016. Epub 2023 Aug 1.

    PMID: 38462265DERIVED

MeSH Terms

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Central Study Contacts

Louis BENAZET

CONTACT

+33 381 219 147lbenazet@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 19, 2019

Study Start

December 4, 2019

Primary Completion

December 31, 2021

Study Completion

June 15, 2022

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)