Phase 4
N=70
24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E
Abortion, Second Trimester
Bottom Line
View on ClinicalTrials.gov: NCT03134183 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Procedure Time — 9.5; 9.9 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vaginal Misoprostol (Drug); Buccal Misoprostol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Time |
9.5; 9.9 | — |
| SECONDARY Cervical Dilation |
49.6; 46.2 | — |
Summary
This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).
Eligibility Criteria
Inclusion Criteria
- The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.
Exclusion Criteria
- Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol
Data sourced from ClinicalTrials.gov (NCT03134183). 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.