CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Mifepristone +1 moredrug
Likely dose
Mifepristone 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01436279
NCT01436279Phase 3Completed
CompareCT.gov

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

Boston University·interventional·Posted Sep 19, 2011·Updated Jun 14, 2017

In Brief

A Phase 3 clinical trial evaluating Mifepristone and osmotic dilators for Cervical Preparation. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Preparation
CountriesUnited States
CollaboratorsSociety of Family Planning

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.8 years ago

Interventions

Mifepristonedrug

200 mg po 20-24 hours prior to the procedure

osmotic dilatorsdevice

osmotic dilators placed in the cervix 20-24 hours prior to the procedure