Recruiting
Phase 1

Mifepristone vs. Misoprostol

Sponsor:

Montefiore Medical Center

Code:

NCT06502158

Conditions

Cervical Preparation

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Mifepristone

Misoprostol

Study Details

Brief summary:

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.

Conditions

Cervical Preparation

Study ID

NCT06502158

Start date

Oct 31, 2024

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Mifepristone

200 milligrams (mg)

Misoprostol

600 micrograms (ug)

Primary outcome measure

  • Percentage of participants achieving Intended dilation [ Time Frame: At time of surgery ]

Central Contacts and Locations

Central contacts

Laura Fletcher, MD, MPH

516-587-3297lfletcher@montefiore.org

Antoinette Danvers, MD, MSCR, MBA

718-405-8260adanvers@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Laura Fletcher, MD, MPH

516-587-3297lfletcher@montefiore.org

Principal Investigator:

Antoinette Danvers, MD, MSCR, MBA

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Procedural Abortion
  • Surgical Abortion
  • Abortion, First Trimester
  • Cervical Dilators

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-24.