Recruiting

Mifepristone vs. Misoprostol for Cervical Preparation in Procedural Abortion

Study Aim

The study aims to evaluate the effectiveness of Mifepristone versus Misoprostol in preparing the cervix for procedural abortion by measuring the percentage of participants achieving the intended dilation.

What is being tested

Mifepristone

+ Misoprostol

Drug

Who is being recruted

From 18 to 45 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: October 2024

See protocol details

Summary

Principal SponsorMontefiore Medical Center

Study ContactLaura Fletcher, MD, MPHMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 31, 2024

Actual date on which the first participant was enrolled.

This study aims to compare two medications, Mifepristone and Misoprostol, to find out which is more effective for preparing the cervix before an abortion procedure between 12 to 16 weeks of pregnancy. Cervical preparation is crucial because it helps reduce the risk of surgical complications during an abortion. Misoprostol is commonly used because it allows for same-day procedures, but it can cause side effects like pain and stomach issues. On the other hand, Mifepristone is easier on patients but requires a longer preparation time. This study is especially important as it seeks to improve the experience and safety for those needing abortion care in hospital settings, particularly in academic centers offering training in abortion procedures. In this study, the procedure will be performed in a hospital's main operating room, and patients will be under sedation or general anesthesia. The research involves administering a local anesthetic, called a paracervical block with lidocaine, to manage pain. The study evaluates how well each medication works in preparing the cervix, looking at factors like ease of the procedure and patient comfort. As cervical preparation is a critical step in safe abortion care, finding the best method could improve the overall safety and experience for patients needing these services.

Official TitleMifepristone 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

NCT06502158

Principal SponsorMontefiore Medical Center

Study ContactLaura Fletcher, MD, MPHMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

94 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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)

9 exclusion criteria prevent from participating

History of more than two prior Cesarean deliveries

Sonographic evidence of placenta previa

Sonographic concern for morbidly adherent placenta

Prior obstetric hemorrhage requiring transfusion

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Montefiore Medical Center

The Bronx, United StatesOpen Montefiore Medical Center in Google Maps

Recruiting

One Study Center