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NCT03407625 · ClinicalTrials.gov registry record · NA

Foley Bulb With Oral Misoprostol for Induction of Labor

A NA study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
2,227
Enrollment target

NCT03407625: Completed NA study, sponsored by University of Texas Southwestern Medical Center.

NCT03407625 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 2,227 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03407625, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
2,227 participants
Enrollment target

Study Summary

Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologic methods of cervical ripening and labor induction is abundant, and yet the majority of clinical trials evaluate time to delivery, rather than mode of delivery. This is a prospective, cluster-randomized clinical trial to compare a standard method of induction at our institution (oral misoprostol) with an alternative, commonly used combination method of oral misoprostol and transcervical foley bulb in women with term pregnancies requiring induction of labor.

Primary Outcome

vaginal delivery at first induction

Interventions

  • OTHER Foley bulb plus Oral Misoprostol
  • OTHER Oral Misoprostol

Trial Details

FieldValue
Enrollment Target 2,227 participants
Start Date 2018-01-01
Est. Completion 2019-05-13
Phase NA

What the finished NCT03407625 record still lists

NCT03407625 is an interventional study that assigns participants to a tested intervention. Its 2,227 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (59% higher).

The record links to 0 conditions, and to 2 interventions - of which Foley bulb plus Oral Misoprostol is the first listed.

NCT03407625 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03407625 about?

NCT03407625 is a clinical study titled "Foley Bulb With Oral Misoprostol for Induction of Labor". Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologi...

What is the current status of trial NCT03407625?

This trial is currently completed. It is a NA study. The enrollment target is 2,227 participants. The study started on 2018-01-01. Estimated completion is 2019-05-13.

What interventions are being tested in trial NCT03407625?

The interventions under investigation include: Foley bulb plus Oral Misoprostol (OTHER), Oral Misoprostol (OTHER).

Who is sponsoring clinical trial NCT03407625?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03407625's enrollment target sits among peer trials

2,227 48th of 2000 higher than 1,953 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 NCT03407625, the US trial registry maintained by the National Library of Medicine. NCT03407625 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.