Mifepristone vs Misoprostol

Conditions

• Cervical Preparation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Mifepristone — DRUG
  200 milligrams (mg)
• Misoprostol — DRUG
  600 micrograms (ug)

Study Details

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.

Key Dates

Start date

Oct 31, 2024

Status verified

Aug 2025

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

94 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Laura Fletcher, MD, MPH
  516-587-3297
  [email protected]
• Antoinette Danvers, MD, MSCR, MBA
  718-405-8260
  [email protected]

Locations (1)

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