Primary outcomeMean· at 10 minutes following administration of the first study drug
Uterine Tone Score
| Group | Value (score on a scale) | Spread |
|---|---|---|
| 15-methyl Prostaglandin F2α | 4.7 | 1.9 |
| Methylergonovine Maleate | 4.4 | 1.8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataSecond-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
NCTNCT03584854 (opens ClinicalTrials.gov in a new tab)Other id2018P000775-A
This trial does not test a peptide that PepBank tracks.
- Measures Oxytocin, does not give it. It appears in the eligibility rules.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 100 participants (actual)
- Sponsor
- Brigham and Women's Hospital · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- 1 Mar 2019
- Primary completion
- 22 May 2022
- Completion
- 15 Jun 2022
- First posted
- 12 Jul 2018
- Last update posted
- 16 Oct 2025
- Conditions
- Postpartum Hemorrhage · Uterine Atony
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20192020202120222023
- Ph 4
Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
NCT035848541 Mar 2019 to 15 Jun 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- 15-methyl prostaglandin F2αDrug
- Methylergonovine MaleateDrug
Arms2
Active comparator
15-methyl prostaglandin F2α
IM Carboprost followed by Methylergonovine if needed.
Active comparator
Methylergonovine Maleate
IM Methylergonovine followed by Carboprost if needed.
Primary outcomes1
Outcomes the sponsor listed as primary.
Uterine Tone Score
Time frame · at 10 minutes following administration of the first study drug
Registry description
Uterine contractile tone will be measured on a 0-10 score as assessed by the obstetrician; 0 is 'no tone', 10 is 'perfect tone' or 'excellent tone'.
Secondary outcomes(8)
Uterine Tone Score
Time frame · at 5 minutes following administration of the first study drug
Registry description
Uterine contractile tone will be measured on a 0-10 score as assessed by the obstetrician; 0 is 'no tone', 10 is 'perfect tone' or 'excellent tone'
Number of Subjects Receiving Additional Uterotonic
Time frame · from time of delivery until surgery completion, approximately 1-2 hours
Registry description
An additional second-line uterotonic which is given in the operating room after administration of the first study drug
Number of Subjects Requiring Transfusion
Time frame · within the first 24 hours after delivery of the fetus
Registry description
The need for RBC transfusion due to postpartum blood loss.
Number of Subjects Requiring Additional Intervention
Time frame · within the first 24 hours after delivery of the fetus
Registry description
The need for an additional surgical or radiologic intervention to control postpartum hemorrhage
Quantitative Blood Loss (QBL)
Time frame · from entry to exit from the OR, approximately 2 to 3 hours
Registry description
The total volume of blood loss (in mL), calculated as a conversion from the measured blood loss in weight into its equivalent volume. Weight of blood loss is measured on a QBL scale that weighs surgical drapes, towels, sponges and suction fluid.
Hematocrit Drop
Time frame · from time of preoperative hematocrit value before delivery until time of first postoperative hematocrit (within 24 hours postoperatively).
Registry description
Comparison of the preoperative and first postoperative hematocrit values
Length of Hospital Stay
Time frame · from day of surgery to day of hospital discharge, approximately 3 days in most cases
Registry description
Total duration of hospital stay (in days)
Number of Subjects Experiencing Severe Maternal Morbidity
Time frame · from time of delivery until time of hospital discharge
Registry description
Any unplanned adverse reaction or event with clinical consequences (e.g., cardiovascular event, intubation, ICU admission, hypovolemic shock, transfusion reaction, or adverse study drug reaction)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· at 5 minutes following administration of the first study drug
Uterine Tone Score
| Group | Value (score on a scale) | Spread |
|---|---|---|
| 15-methyl Prostaglandin F2α | 6.8 | 1.9 |
| Methylergonovine Maleate | 6.4 | 1.9 |
Secondary outcomeCount of participants· from time of delivery until surgery completion, approximately 1-2 hours
Number of Subjects Receiving Additional Uterotonic
| Group | Value (Participants) |
|---|---|
| 15-methyl Prostaglandin F2α | 17 |
| Methylergonovine Maleate | 15 |
Secondary outcomeCount of participants· within the first 24 hours after delivery of the fetus
Number of Subjects Requiring Transfusion
| Group | Value (Participants) |
|---|---|
| 15-methyl Prostaglandin F2α | 2 |
| Methylergonovine Maleate | 3 |
Secondary outcomeCount of participants· within the first 24 hours after delivery of the fetus
Number of Subjects Requiring Additional Intervention
| Group | Value (Participants) |
|---|---|
| 15-methyl Prostaglandin F2α | 4 |
| Methylergonovine Maleate | 5 |
Secondary outcomeGeometric mean· from entry to exit from the OR, approximately 2 to 3 hours
Quantitative Blood Loss (QBL)
| Group | Value (milliliters (mL)) |
|---|---|
| 15-methyl Prostaglandin F2α | 713 |
| Methylergonovine Maleate | 758 |
Secondary outcomeMean· from time of preoperative hematocrit value before delivery until time of first postoperative hematocrit (within 24 hours postoperatively).
Hematocrit Drop
| Group | Value (percentage of initial Hct) | Spread |
|---|---|---|
| 15-methyl Prostaglandin F2α | 28.3 | 3.7 |
| Methylergonovine Maleate | 27.7 | 5 |
Secondary outcomeGeometric mean· from day of surgery to day of hospital discharge, approximately 3 days in most cases
Length of Hospital Stay
| Group | Value (days) |
|---|---|
| 15-methyl Prostaglandin F2α | 4.1 |
| Methylergonovine Maleate | 4.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 15-methyl Prostaglandin F2αIM Carboprost followed by Methylergonovine if needed. 15-methyl prostaglandin F2α: 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 Maleate: 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. | 0 / 50 | 0 / 50 | 14 / 50 |
| Methylergonovine MaleateIM Methylergonovine followed by Carboprost if needed. 15-methyl prostaglandin F2α: 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 Maleate: 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. | 0 / 50 | 0 / 50 | 13 / 50 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
More studies
2 studies on this page
Indexing hint: Randomized controlled trial · 2024
Second-Line Uterotonics for Uterine Atony: A Randomized Controlled Trial.
Cole et al. 2024Obstetrics and gynecologycited by 1
PMID 39326051DOI 10.1097/aog.0000000000005744PUB-39326051
Full text at the publisher
Indexing hint: Systematic review · 2020
Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis.
Parry Smith et al. 2020The Cochrane database of systematic reviewscited by 31
PMID 33232518PMC8130992DOI 10.1002/14651858.cd012754.pub2PUB-33232518
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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