MedTrace Logo

Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

NCT01615731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-13

Study results available
· View outcomes & findings →

Summary

A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

Conditions

  • Abortion, Induced

Interventions

DRUG

Mifepristone

200mg Mifepristone orally

OTHER

Hygroscopic cervical dilators

Dilapan-S osmostic cervical dilators inserted through the internal os

DRUG

Misoprostol

400mcg buccal misoprostol 90 minutes pre-op

DRUG

Intra-amniotic digoxin

1mg digoxin administered intra-amniotically \~24 hours pre-op

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01615731 on ClinicalTrials.gov