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Phase 4 Completed N=100 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT03584854 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Uterine Tone Score — 4.7; 4.4 score on a scale
◆ Published Evidence
Established
61citations · ~10 / year
Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis.
The Cochrane database of systematic reviews · 2020 · Open access · Likely link

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.

Linked Publications (2)

  • Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis.
    The Cochrane database of systematic reviews · 2020 · 61 citations · Open access · Likely link
  • Second-Line Uterotonics for Uterine Atony: A Randomized Controlled Trial.
    Obstetrics and gynecology · 2024 · 4 citations · Likely link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03584854) and the linked publication. 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. Informational only — not medical advice.

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