Phase 4
N=100
Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
Postpartum Hemorrhage · Uterine Atony
Bottom Line
View on ClinicalTrials.gov: NCT03584854 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Uterine Tone Score — 4.7; 4.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 15-methyl prostaglandin F2α (Drug); Methylergonovine Maleate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uterine Tone Score |
6.8; 6.4 | — |
| SECONDARY Uterine Tone Score |
6.8; 6.4 | — |
| SECONDARY Number of Subjects Receiving Additional Uterotonic |
17; 15 | — |
| SECONDARY Number of Subjects Requiring Transfusion |
2; 3 | — |
| SECONDARY Number of Subjects Requiring Additional Intervention |
4; 5 | — |
| SECONDARY Quantitative Blood Loss (QBL) |
713; 758 | — |
| SECONDARY Hematocrit Drop |
28.3; 27.7 | — |
| SECONDARY Length of Hospital Stay |
4.1; 4.4 | — |
| SECONDARY Number of Subjects Experiencing Severe Maternal Morbidity |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03584854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.