Mifepristone vs Misoprostol

August 7, 2025 updated by: Montefiore Medical Center

Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial

The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond. The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended. Cervical preparation options include misoprostol, mifepristone, and cervical dilators. Regimen choice is often guided by provider comfort, preference, or institutional guidelines. Misoprostol offers the advantage of facilitating same-day procedures, but side effects like pain and gastrointestinal symptoms can negatively affect patients' experiences. Furthermore, using misoprostol can pose logistical challenges in hospital-based main operating room environments, where abortions occur concurrently with all other surgical cases. Mifepristone is better tolerated than misoprostol but requires a multiple-day protocol for administration, which can pose logistical challenges.

Several studies demonstrate mifepristone's efficacy and safety as a cervical ripening agent for up to 16 weeks' gestation, however, despite its effectiveness, mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost. Recent studies demonstrating mifepristone's adjunctive benefit with osmotic dilators later in pregnancy, however, have broadened its use.

While most abortion care in the United States occurs in outpatient settings, about 3% occur in hospitals. This is expected to increase as the Dobbs versus Jackson Women's Health Organization decision exacerbates disparities in abortion access. In hospital-based abortion care, particularly at academic centers providing abortion training, there is a pressing need for innovative measures for cervical ripening. The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons. Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Antoinette Danvers, MD, MSCR, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English or Spanish-speaking
  • Capacity to consent
  • Seeking induced abortion of a singleton pregnancy
  • Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)

Exclusion Criteria:

  • History of more than two prior Cesarean deliveries
  • Sonographic evidence of placenta previa
  • Sonographic concern for morbidly adherent placenta
  • Prior obstetric hemorrhage requiring transfusion
  • Obstructive cervical or lower uterine segment fibroid
  • Current therapeutic anticoagulation use
  • Cerclage in situ
  • History of more than one prior cervical excisional procedure
  • BMI greater than 50 kg/m^2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
Patients will be randomized to Misoprostol-alone in a 1:1 ratio prior to procedural abortions. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
Drug: Misoprostol
600 micrograms (ug)
Other Names:
  • Cytotec
Experimental: Mifepristone
Patients will be randomized to Mifepristone-alone in a 1:1 manner prior to procedural abortions. A paracervical block of 20 cubic centimeters (cc) 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
Drug: Mifepristone
200 milligrams (mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Intended dilation
Time Frame: At time of surgery
The proportion of participants achieving intended dilation at the start of the procedure will be summarized by treatment group and reported in percentages. Achievement of intended dilation will be determined by the attending surgeon. Overdilation resulting in passage of products of conception prior to time of surgery will be characterized as a treatment failure.
At time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical dilation at start of procedure
Time Frame: Start of the Procedure
Cervical dilation in centimeters (cm) at start of procedure will be summarized and reported using basic descriptive statistics.
Start of the Procedure
Surgical time
Time Frame: Start to end of procedure, up to 4 hours
Total surgical time will quantified and reported by treatment arm using basic descriptive statistics.
Start to end of procedure, up to 4 hours
Estimated blood loss
Time Frame: Start to end of procedure, up to 4 hours
Estimated blood loss will be quantified and reported per treatment arm using basic descriptive statistics.
Start to end of procedure, up to 4 hours
Presence of Intraoperative Complications
Time Frame: From preoperative visit to discharge, up to 2 days
The presence of peri-operative complications, defined as instances of hemorrhage, use of uterotonic medications, passage of products of conception prior to time of surgery, instances of extramural delivery, or need for unscheduled procedures, will be summarized and reported as "Yes" or "No" using basic descriptive statistics.
From preoperative visit to discharge, up to 2 days
Patient Satisfaction
Time Frame: From preoperative visit to discharge, up to 2 days
Patient Satisfaction will be assessed by responses to a survey administered in the Postoperative Care Unit (PACU) following the procedure. The patient will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction.
From preoperative visit to discharge, up to 2 days
Provider Satisfaction
Time Frame: From preoperative visit to discharge, up to 2 days
Provider Satisfaction will be assessed by responses to a survey administered following the procedure. The care provider will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction.
From preoperative visit to discharge, up to 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Antoinette Danvers, MD, MSCR, MBA, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-15999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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