Overview

Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Status:
Terminated
Trial end date:
2021-02-26
Target enrollment:
0
Participant gender:
Female
Summary
The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D&E) procedures.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, Davis
Collaborator:
Society of Family Planning
Treatments:
Mifepristone
Criteria
Inclusion Criteria:

A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on
procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing
to sign informed consent and follow study protocol

Exclusion Criteria:

A. Allergy or known intolerance to mifepristone

B. Known contraindication to mifepristone for cervical preparation prior to dilation and
evacuation:

1. Chronic adrenal failure or insufficiency

2. Concurrent use of long-term corticosteroid therapy

3. Inherited porphyrias

C. Any condition that in the opinion of the investigator could impede study participation
or collection of study data