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Fetal Pillow insertion for Breech Birth

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
  • Breech Presentation
  • External Cephalic Version

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient arrival to labor unit for ecv procedure and discharge home (up to 72 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient arrival to labor unit for ecv procedure and discharge home (up to 72 hours) for reporting.

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 more

Trial 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

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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
~2 spots leftby Nov 2025
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