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NCT01519765 · ClinicalTrials.gov registry record · Phase 4

Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

A Phase 4 study, sponsored by University of California, Los Angeles.

Terminated
Registry status
Phase 4
Development phase
73
Enrollment target

NCT01519765: Clinical Trial Phase 4 study, sponsored by University of California, Los Angeles.

NCT01519765 is a Phase 4 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 73 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01519765, a Phase 4 study, was terminated before completion, sponsored by University of California, Los Angeles.

TERMINATED
Registry status
Phase 4
Development phase
73 participants
Enrollment target

Study Summary

Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It stimulates both cervical ripening and uterine contractions, thus making it an ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of different administration routes and effects on uterine contractility, side effects, and safety. Vaginal misoprostol has been shown to be superior over oral administration however patients often prefer a more tolerable route. Buccal administration has already been shown to be as effective as vaginal misoprostol for cervical ripening and induction in both first trimester and second trimester abortions. There is minimal research comparing buccal versus vaginal for third trimester induction of labor. The investigators study is a prospective, double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.

Primary Outcome

Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.

Interventions

  • DRUG Buccal Misoprostol
  • DRUG Vaginal misoprostol

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2011-07
Est. Completion 2014-12
Phase Phase 4

Why NCT01519765 stopped before completion

NCT01519765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Buccal Misoprostol is the first listed.

NCT01519765 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01519765 about?

NCT01519765 is a clinical study titled "Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor". Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It stimulates both cervical ripening and uterine contractions, thus making it an ideal induction agent fo...

What is the current status of trial NCT01519765?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 73 participants. The study started on 2011-07. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01519765?

The interventions under investigation include: Buccal Misoprostol (DRUG), Vaginal misoprostol (DRUG).

Who is sponsoring clinical trial NCT01519765?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01519765's enrollment target sits among peer trials

73 1033rd of 2000 higher than 966 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01519765, the US trial registry maintained by the National Library of Medicine. NCT01519765 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.