CompletedPhase 4

Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial

United States100 participantsStarted 2019-03-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * non-emergent cesarean delivery * ASA I-III * postpartum hemorrhage deemed the result of uterine atony (uterine atony at the time of delivery, despite the administration of oxytocin) Exclusion Criteria: * non-English speaking patients requiring an interpreter for urgent, unscheduled delivery * any hypertensive disorder * cardiovascular disease * asthma * refusal of transfused blood products * coagulopathy or abnormal coagulation lab values * hypersensitivity to methylergonovine maleate or 15-methyl prostaglandin * known or suspected delayed postpartum hemorrhage after leaving the operating room

What they're measuring

Uterine Tone Score

Timeframe: at 10 minutes following administration of the first study drug

Trial details

NCT IDNCT03584854

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-22

Results submitted2024-05-28

View on ClinicalTrials.gov More Postpartum Hemorrhage trials