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Clinical Trials/NCT04169035
NCT04169035UnknownNot Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country104 target enrollmentStarted: December 4, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
104
Locations
1
Primary Endpoint
Rate of births successfully assisted with the BD Odon Device
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Rate of births successfully assisted with the BD Odon Device

Time Frame: 3 months after delivery

Successful vaginal birth with the BD ODON DeviceTM: successful BD Odon assisted birth in the absence of maternal and neonatal serious adverse reactions

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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