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Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

NCT02679092 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-09-19

No results posted yet for this study

Summary

Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\&E.

Conditions

  • Legally Induced Abortion Without Mention of Complication

Interventions

DRUG

Misoprostol

400 mcg buccal 60-90 minutes prior to procedure

DRUG

Mifepristone

200 mg PO on the day prior to D\&E

DEVICE

Hygroscopic cervical dilators

osmotic cervical dilators inserted through the internal os

Sponsors & Collaborators

Principal Investigators

  • Principal Investigator · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-02-29
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02679092 on ClinicalTrials.gov