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Elevation of the Fetal Buttocks Prior to External Cephalic Version
N/A
Waitlist Available
Led By David A Hill, MD
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after ecv procedure or during subsequent labor and delivery
Summary
This trial tests a balloon device called the Fetal Pillow, which helps lift a breech baby's bottom to make it easier to turn them head-first. It targets first-time pregnant women in the later stages of pregnancy with breech babies. The balloon is inflated inside the vagina to assist in turning the baby.
Eligible Conditions
- Breech Birth
- External Cephalic Version
- Breech Presentation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patient arrival to labor unit for ecv procedure and discharge home (up to 72 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient arrival to labor unit for ecv procedure and discharge home (up to 72 hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Successful external cephalic version
Secondary study objectives
Cesarean delivery
Cost of ECV procedure and hospital stay (mother)
Cost of ECV procedure and hospital stay (neonate)
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Inflation of the balloon device
Group II: ControlPlacebo Group1 Intervention
Non-inflation of the balloon device
Find a Location
Who is running the clinical trial?
AdventHealthLead Sponsor
115 Previous Clinical Trials
31,354 Total Patients Enrolled
Ariana MoraStudy DirectorAdventHealth
David A Hill, MDPrincipal InvestigatorAdventHealth
1 Previous Clinical Trials
120 Total Patients Enrolled