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NCT01436279 · ClinicalTrials.gov registry record · Phase 3

Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

A Phase 3 study, sponsored by Boston University.

Completed
Registry status
Phase 3
Development phase
50
Enrollment target

NCT01436279 is a Phase 3 study that has completed, run by Boston University. The registered enrollment target is 50 participants.

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The verdict

NCT01436279, a Phase 3 study, has completed, sponsored by Boston University.

COMPLETED
Registry status
Phase 3
Development phase
50 participants
Enrollment target

Study Summary

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Interventions

  • DRUG Mifepristone
  • DEVICE osmotic dilators

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2011-07
Est. Completion 2013-08
Phase Phase 3

Sponsor

Boston University

185 total trials

What the Registry Record Tells You About NCT01436279

The ClinicalTrials.gov registry entry for NCT01436279 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.

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

NCT01436279 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01436279 about?

NCT01436279 is a clinical study titled "Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks". In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion....

What is the current status of trial NCT01436279?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2011-07. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01436279?

The interventions under investigation include: Mifepristone (DRUG), osmotic dilators (DEVICE).

Who is sponsoring clinical trial NCT01436279?

This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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