CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 211 enrolled
Drug / intervention
Misoprostol 400mcg Tab +1 moredrug
Likely dose
Misoprostol 400mcg Tabfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02957305
NCT02957305Phase 4Completed
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Comparison Between 400 µg or 200 µg of Misoprostol for Cervical Dilatation in 1st Trimester Miscarriage - A Clinical Trial

Hospital de Clinicas de Porto Alegre·interventional·Posted Nov 7, 2016·Updated Apr 30, 2021

In Brief

A Phase 4 clinical trial evaluating Misoprostol 400mcg Tab and Misoprostol 200mcg Tab for Miscarriage in First Trimester. Completed, enrolled 211 participants across 1 site.

Detailed Summary

Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMiscarriage in First Trimester
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 7, 2016
Enrollment StartDec 21, 2016
Primary CompletionOct 19, 2019
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.7 years ago

Interventions

Misoprostol 400mcg Tabdrug

400µg of misoprostol (2 tablets)

Misoprostol 200mcg Tabdrug

200µg of misoprostol (1 tablet)