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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02679092

Enrollment

Registered

2016-02-10

Start date

2016-04-30

Completion date

2020-12-31

Last updated

2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Legally Induced Abortion Without Mention of Complication

Keywords

Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators, Misoprostol

Brief 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.

Interventions

DRUGMisoprostol

400 mcg buccal 60-90 minutes prior to procedure

DRUGMifepristone

200 mg PO on the day prior to D&E

DEVICEHygroscopic cervical dilators

osmotic cervical dilators inserted through the internal os

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \>18 Years Old * Viable, Singleton pregnancy * Voluntarily seeking abortion between 14-19 weeks gestation * Able to give informed consent and comply with study protocol * Fluent in English or Spanish

Exclusion criteria

* Allergy to study drugs

Design outcomes

Primary

Measure	Time frame	Description
Procedure Time	Intraoperative	Measured as time from speculum insertion to removal.

Secondary

Measure	Time frame	Description
Total Procedure Time	Measured at clinic visit and on OR day, over 2 day period	All time required by patient (time in clinic for cervical preparation procedures)
Difficulty of Procedure, as reported by clinician	Measured within 5 minutes after procedure	Using Visual Analogue Scale (VAS)
Cervical Dilation	Baseline	Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure
Pain Perceived by Patient	Intraoperatively Measured during dilator placement	Using Visual Analogue Scale (VAS)
Overall Patient Experience	Measured post-operatively (30 minutes prior to discharge)	Using Visual Analogue Scale (VAS)
Complications/Adverse Events	Intraoperatively	Estimated blood loss, uterine injury, infection, retained products of conception

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026