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NCT04538261 · ClinicalTrials.gov registry record · NA

Elevation of the Fetal Buttocks Prior to External Cephalic Version

A NA study, sponsored by AdventHealth.

Terminated
Registry status
NA
Development phase
11
Enrollment target

NCT04538261: Clinical Trial NA study, sponsored by AdventHealth.

NCT04538261 is a NA study that was terminated before completion, run by AdventHealth. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04538261, a NA study, was terminated before completion, sponsored by AdventHealth.

TERMINATED
Registry status
NA
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Successful conversion of breech fetus to cephalic presentation

Interventions

  • DEVICE Fetal Pillow insertion

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-11-01
Est. Completion 2023-01-31
Phase NA
AdventHealth

95 total trials

Why NCT04538261 stopped before completion

NCT04538261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Fetal Pillow insertion is the first listed.

NCT04538261 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04538261 about?

NCT04538261 is a clinical study titled "Elevation of the Fetal Buttocks Prior to External Cephalic Version". 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...

What is the current status of trial NCT04538261?

This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2020-11-01. Estimated completion is 2023-01-31.

What interventions are being tested in trial NCT04538261?

The interventions under investigation include: Fetal Pillow insertion (DEVICE).

Who is sponsoring clinical trial NCT04538261?

This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04538261's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04538261, the US trial registry maintained by the National Library of Medicine. NCT04538261 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.