CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Vaginal Misoprostol +1 moredrug
Likely dose
Mifepristone 200 mg orally, followed 20–24 hours later by misoprostol 400 mcg (either buccally or vaginally)AI-extracted
Key inclusion· 3
  • ✓English or Spanish-speaking women over 18 years old
  • ✓Eligible for non-urgent D&E at 16 0/7 to 20 6/7 weeks gestation confirmed by ultrasound
  • ✓Willing and able to provide informed consent
Key exclusion· 5
  • ✕Emergent need for D&E
  • ✕Intrauterine infection
  • ✕Fetal demise
  • ✕Molar pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03134183
NCT03134183Phase 4Completed
CompareCT.gov

A Randomized Double-blinded Comparison of 24-hour Interval-Mifepristone and Buccal Misoprostol Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation in Second-Trimester Surgical Abortion

Virginia Commonwealth University·interventional·Posted Apr 28, 2017·Updated Jul 18, 2018

In Brief

A Phase 4 clinical trial evaluating Vaginal Misoprostol and Buccal Misoprostol for Abortion, Second Trimester. Completed, enrolled 70 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbortion, Second Trimester
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 28, 2017
Enrollment StartNov 19, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.2 years ago

Interventions

Vaginal Misoprostoldrug

Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E

Buccal Misoprostoldrug

Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E