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NCT Number: NCT06502158

Mifepristone vs Misoprostol

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Antoinette Danvers, MD, MSCR, MBA

PRINCIPAL_INVESTIGATOR

Laura Fletcher, MD, MPH

CONTACT

[email protected]

516-587-3297

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

200 milligrams (mg)

Misoprostol

Drug

600 micrograms (ug)

Other names: Cytotec

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoinette Danvers, MD, MSCR, MBA

CONTACT

[email protected]

718-405-8260

Laura Fletcher, MD, MPH

CONTACT

[email protected]

516-587-3297

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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