CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
15-methyl prostaglandin F2α +1 moredrug
Likely dose
15-methyl prostaglandin F2α 0.25mgfrom 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/NCT03584854
NCT03584854Phase 4Completed
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Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial

Brigham and Women's Hospital·interventional·Posted Jul 12, 2018·Updated Oct 16, 2025

In Brief

A Phase 4 clinical trial evaluating 15-methyl prostaglandin F2α and Methylergonovine Maleate for Postpartum Hemorrhage and Uterine Atony. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate in a randomized fashion the comparative efficacy of two second-line medications, methylergonovine and carboprost for treating atonic postpartum hemorrhage (PPH). The investigators hypothesize that administration of methylergonovine will produce superior uterine tone to carboprost in atonic PPH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Hemorrhage, Uterine Atony
CountriesUnited States
CollaboratorsNorthwestern Memorial Hospital

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 12, 2018
Enrollment StartMar 1, 2019
Primary CompletionMay 22, 2022
Study CompletionJun 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.0 years ago

Interventions

15-methyl prostaglandin F2αdrug

Participants will receive standard intraoperative care including an infusion of oxytocin immediately postpartum. If a second-line uterotonic is requested, patients randomized to the "carboprost" study group will receive an intramuscular dose of 0.25mg (1mL) carboprost. If another second-line uterotonic is requested, the patients will receive 0.2mg (1mL) intramuscular methylergonovine.

Methylergonovine Maleatedrug

Participants will receive standard intraoperative care including an infusion of oxytocin immediately postpartum. If a second-line uterotonic is requested, patients randomized to the "methergine" study group will receive an intramuscular dose of 0.2mg (1mL) methylergonovine. If another second-line uterotonic is requested, the patients will receive 0.25mg (1mL) intramuscular carboprost.