Phase 4 N=100 Randomized Triple-blind Treatment

Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

Induced Abortion

Bottom Line

View on ClinicalTrials.gov: NCT02412618 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Initial Cervical Dilation — 11.7; 10.9 mm

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Mifepristone (Drug); Misoprostol (Drug); Placebo (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Medstar Health Research Institute
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Initial Cervical Dilation	11.7; 10.9	—
SECONDARY Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)	4; 4; 4; 4	—

Summary

A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Eligibility Criteria

Inclusion Criteria

healthy women
eligible for non---urgent D&E
14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

Exclusion Criteria

emergent need for D&E
fetal demise
intolerance
allergy or contraindication to mifepristone or misoprostol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02412618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.