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

Pregnant Woman Clinical Trial

— ASSIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169035
• Other study ID #: P/2019/435
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Louis BENAZET
• Phone: +33 381 219 147
• Email: lbenazet[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Woman

Intervention

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.

Locations

Country	Name	City	State
France	Chu Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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