CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 284 enrolled
Drug / intervention
Methergine +1 moredrug
Likely dose
Methergine 0.2 mgfrom 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/NCT02408965
NCT02408965Phase 4Completed

A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion

University of California, San Francisco·interventional·Posted Apr 6, 2015·Updated Sep 6, 2019

In Brief

A Phase 4 clinical trial evaluating Methergine and placebo for Hemorrhage. Completed, enrolled 284 participants across 1 site.

Detailed Summary

Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 6, 2015
Enrollment StartMar 1, 2015
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.2 years ago

Interventions

Metherginedrug

0.2 mg of methylergonovine maleate

placeboother

saline placebo to maintain blinding