Trial Outcomes & Findings for Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial (NCT NCT03584854)
NCT ID: NCT03584854
Last Updated: 2025-10-16
Results Overview
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'.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
at 10 minutes following administration of the first study drug
Results posted on
2025-10-16
Participant Flow
March 2019- April 2022
Participant milestones
| Measure |
15-methyl Prostaglandin F2α
IM 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.
|
Methylergonovine Maleate
IM 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.
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|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
15-methyl Prostaglandin F2α
IM 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.
|
Methylergonovine Maleate
IM 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.
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|---|---|---|
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Overall Study
Primary outcome not measured
|
1
|
2
|
Baseline Characteristics
Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 10 minutes following administration of the first study drugPopulation: 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.
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'.
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=49 Participants
IM 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.
|
Methylergonovine Maleate
n=48 Participants
IM 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.
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|---|---|---|
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Uterine Tone Score
|
4.7 score on a scale
Standard Deviation 1.9
|
4.4 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: at 5 minutes following administration of the first study drugPopulation: 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.
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'
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=49 Participants
IM 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.
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|---|---|---|
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Uterine Tone Score
|
6.8 score on a scale
Standard Deviation 1.9
|
6.4 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: from time of delivery until surgery completion, approximately 1-2 hoursAn additional second-line uterotonic which is given in the operating room after administration of the first study drug
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
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|---|---|---|
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Number of Subjects Receiving Additional Uterotonic
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: within the first 24 hours after delivery of the fetusThe need for RBC transfusion due to postpartum blood loss.
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
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|---|---|---|
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Number of Subjects Requiring Transfusion
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: within the first 24 hours after delivery of the fetusThe need for an additional surgical or radiologic intervention to control postpartum hemorrhage
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
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|---|---|---|
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Number of Subjects Requiring Additional Intervention
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: from entry to exit from the OR, approximately 2 to 3 hoursThe 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.
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
|
|---|---|---|
|
Quantitative Blood Loss (QBL)
|
713 milliliters (mL)
Interval 621.0 to 820.0
|
758 milliliters (mL)
Interval 636.0 to 903.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
|
|---|---|---|
|
Hematocrit Drop
|
28.3 percentage of initial Hct
Standard Deviation 3.7
|
27.7 percentage of initial Hct
Standard Deviation 5
|
SECONDARY outcome
Timeframe: from day of surgery to day of hospital discharge, approximately 3 days in most casesTotal duration of hospital stay (in days)
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
|
|---|---|---|
|
Length of Hospital Stay
|
4.1 days
Interval 3.7 to 4.6
|
4.4 days
Interval 4.1 to 4.7
|
SECONDARY outcome
Timeframe: from time of delivery until time of hospital dischargeAny unplanned adverse reaction or event with clinical consequences (e.g., cardiovascular event, intubation, ICU admission, hypovolemic shock, transfusion reaction, or adverse study drug reaction)
Outcome measures
| Measure |
15-methyl Prostaglandin F2α
n=50 Participants
IM 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.
|
Methylergonovine Maleate
n=50 Participants
IM 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.
|
|---|---|---|
|
Number of Subjects Experiencing Severe Maternal Morbidity
|
0 Participants
|
0 Participants
|
Adverse Events
15-methyl Prostaglandin F2α
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Methylergonovine Maleate
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15-methyl Prostaglandin F2α
n=50 participants at risk
IM 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.
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Methylergonovine Maleate
n=50 participants at risk
IM 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.
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|---|---|---|
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Gastrointestinal disorders
nausea
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28.0%
14/50 • Number of events 14 • Adverse events were collected for each participant from the time of delivery until 1 month postpartum.
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26.0%
13/50 • Number of events 13 • Adverse events were collected for each participant from the time of delivery until 1 month postpartum.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place