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Elevation of the Fetal Buttocks Prior to External Cephalic Version

NCT04538261 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-03

Study results available
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Summary

This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures. Eligible study population: nulliparous pregnant women between 37-40 weeks estimated gestational age with a breech presenting fetus and no contraindications to external cephalic version.

Conditions

  • Breech Presentation
  • External Cephalic Version

Interventions

DEVICE

Fetal Pillow insertion

Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • David A Hill, MD · AdventHealth

  • Ariana Mora · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538261 on ClinicalTrials.gov