Trial · NCT03584854
Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
NCT03584854, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2025-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial. Trials, record NCT03584854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03584854
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
- NCT number
- NCT03584854
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 100 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Interventions
- 15-methyl prostaglandin F2α, Methylergonovine Maleate
- First posted
- 2018-07-12
- Last updated
- 2025-10-16
- Results first posted
- 2025-10-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Uterine Tone Score | at 10 minutes following administration of the first study drug | 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 | Uterine Tone Score | at 5 minutes following administration of the first study drug | 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 | Number of Subjects Receiving Additional Uterotonic | from time of delivery until surgery completion, approximately 1-2 hours | An additional second-line uterotonic which is given in the operating room after administration of the first study drug |
| Secondary | Number of Subjects Requiring Transfusion | within the first 24 hours after delivery of the fetus | The need for RBC transfusion due to postpartum blood loss. |
| Secondary | Number of Subjects Requiring Additional Intervention | within the first 24 hours after delivery of the fetus | The need for an additional surgical or radiologic intervention to control postpartum hemorrhage |
| Secondary | Quantitative Blood Loss (QBL) | from entry to exit from the OR, approximately 2 to 3 hours | 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. |
| Secondary | Hematocrit Drop | from time of preoperative hematocrit value before delivery until time of first postoperative hematocrit (within 24 hours postoperatively). | Comparison of the preoperative and first postoperative hematocrit values |
| Secondary | Length of Hospital Stay | from day of surgery to day of hospital discharge, approximately 3 days in most cases | Total duration of hospital stay (in days) |
| Secondary | Number of Subjects Experiencing Severe Maternal Morbidity | from time of delivery until time of hospital discharge | 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) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Uterine Tone Score | at 10 minutes following administration of the first study drug | In the carboprost group, 50 participants were enrolled and data for 49 participants were analyzed since the primary outcome was not measured in 1 participant. In the methylergonovine group, 50 participants were enrolled and data for 48 were analyzed since 2 participants did not have the primary outcome measured. | score on a scale | MEAN |
| SECONDARY | Uterine Tone Score | at 5 minutes following administration of the first study drug | 50 participants were enrolled in the 15-methyl prostaglandin F2alpha group, and this secondary outcome was measured in all participants. 50 participants were enrolled in the methylergonovine group, but 1 did not have this secondary outcome (uterine tone score 5 minutes after administration of the first study drug) measured, therefore 49 were analyzed. | score on a scale | MEAN |
| SECONDARY | Number of Subjects Receiving Additional Uterotonic | from time of delivery until surgery completion, approximately 1-2 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Requiring Transfusion | within the first 24 hours after delivery of the fetus | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Requiring Additional Intervention | within the first 24 hours after delivery of the fetus | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quantitative Blood Loss (QBL) | from entry to exit from the OR, approximately 2 to 3 hours | milliliters (mL) | GEOMETRIC_MEAN | |
| SECONDARY | Hematocrit Drop | from time of preoperative hematocrit value before delivery until time of first postoperative hematocrit (within 24 hours postoperatively). | percentage of initial Hct | MEAN | |
| SECONDARY | Length of Hospital Stay | from day of surgery to day of hospital discharge, approximately 3 days in most cases | days | GEOMETRIC_MEAN | |
| SECONDARY | Number of Subjects Experiencing Severe Maternal Morbidity | from time of delivery until time of hospital discharge | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Uterine Tone Score | 15-methyl Prostaglandin F2α | 4.7 | Standard Deviation 1.9 | score on a scale | |
| Uterine Tone Score | Methylergonovine Maleate | 4.4 | Standard Deviation 1.8 | score on a scale | |
| Uterine Tone Score | 15-methyl Prostaglandin F2α | 6.8 | Standard Deviation 1.9 | score on a scale | |
| Uterine Tone Score | Methylergonovine Maleate | 6.4 | Standard Deviation 1.9 | score on a scale | |
| Number of Subjects Receiving Additional Uterotonic | 15-methyl Prostaglandin F2α | 17 | Participants | ||
| Number of Subjects Receiving Additional Uterotonic | Methylergonovine Maleate | 15 | Participants | ||
| Number of Subjects Requiring Transfusion | 15-methyl Prostaglandin F2α | 2 | Participants | ||
| Number of Subjects Requiring Transfusion | Methylergonovine Maleate | 3 | Participants | ||
| Number of Subjects Requiring Additional Intervention | 15-methyl Prostaglandin F2α | 4 | Participants | ||
| Number of Subjects Requiring Additional Intervention | Methylergonovine Maleate | 5 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 15-methyl Prostaglandin F2α | 50 | |
| Overall Study | STARTED | Methylergonovine Maleate | 50 | |
| Overall Study | COMPLETED | 15-methyl Prostaglandin F2α | 49 | |
| Overall Study | COMPLETED | Methylergonovine Maleate | 48 | |
| Overall Study | NOT COMPLETED | 15-methyl Prostaglandin F2α | 1 | |
| Overall Study | NOT COMPLETED | Methylergonovine Maleate | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | 15-methyl Prostaglandin F2α | 14 | 50 | 14 |
| other | nausea | Gastrointestinal disorders | Methylergonovine Maleate | 13 | 50 | 13 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 15-methyl Prostaglandin F2α | 0 | 50 |
| Total, all-cause mortality | Methylergonovine Maleate | 0 | 50 |
| Total, other adverse events | 15-methyl Prostaglandin F2α | 14 | 50 |
| Total, other adverse events | Methylergonovine Maleate | 13 | 50 |
| Total, serious adverse events | 15-methyl Prostaglandin F2α | 0 | 50 |
| Total, serious adverse events | Methylergonovine Maleate | 0 | 50 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 15-methyl Prostaglandin F2α vs Methylergonovine Maleate: Number of Subjects Requiring Additional Intervention | Trial comparisons |
| 15-methyl Prostaglandin F2α vs Methylergonovine Maleate: Number of Subjects Requiring Transfusion | Trial comparisons |
| 15-methyl Prostaglandin F2α vs Methylergonovine Maleate: Number of Subjects Receiving Additional Uterotonic | Trial comparisons |
| 15-methyl Prostaglandin F2α vs Methylergonovine Maleate: Number of Subjects Experiencing Severe Maternal Morbidity | Trial comparisons |
| 15-methyl Prostaglandin F2α vs Methylergonovine Maleate: deaths from any cause | Trial comparisons |
| 15-methyl Prostaglandin F2α vs Methylergonovine Maleate: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03584854
GET https://conductscience.org/api/trials/v1/NCT03584854/registered