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24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E

NCT03134183 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-07-18

Study results available
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Summary

This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal misoprostol for cervical preparation for second trimester dilation and evacuation (D\&E).

Conditions

  • Abortion, Second Trimester

Interventions

DRUG

Buccal Misoprostol

Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E

DRUG

Vaginal Misoprostol

Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Frances Casey, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-19
Primary Completion
2017-08-01
Completion
2017-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134183 on ClinicalTrials.gov