RecruitingPhase 1NCT06502158

Mifepristone vs Misoprostol

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


Sponsor

Montefiore Medical Center

Enrollment

94 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

DRUGMifepristone

200 milligrams (mg)

DRUGMisoprostol

600 micrograms (ug)


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT06502158