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Trial Outcomes & Findings for Prophylactic Methylergonovine for Twin Cesarean (NCT NCT05772156)

NCT ID: NCT05772156

Last Updated: 2025-06-13

Results Overview

The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

Baseline and Postoperative Day 1 (Approximately 48 hours)

Results posted on

2025-06-13

Participant Flow

Participant milestones

Participant milestones
Measure
Prophylactic Methylergonovine
Prophylactic methylergonovine 200mcg IM
Placebo
Normal Saline 1mL
Overall Study
STARTED
33
33
Overall Study
COMPLETED
33
33
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Methylergonovine for Twin Cesarean

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo
n=33 Participants
Normal Saline 1mL
Total
n=66 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
33 Participants
n=99 Participants
33 Participants
n=107 Participants
66 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
33 Participants
n=99 Participants
33 Participants
n=107 Participants
66 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=99 Participants
9 Participants
n=107 Participants
20 Participants
n=206 Participants
Race (NIH/OMB)
White
22 Participants
n=99 Participants
22 Participants
n=107 Participants
44 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants
n=99 Participants
14 Participants
n=107 Participants
29 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=99 Participants
19 Participants
n=107 Participants
37 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Number of Prior Cesarean Deliveries, n (%)
0
23 Participants
n=99 Participants
24 Participants
n=107 Participants
47 Participants
n=206 Participants
Number of Prior Cesarean Deliveries, n (%)
1
7 Participants
n=99 Participants
7 Participants
n=107 Participants
14 Participants
n=206 Participants
Number of Prior Cesarean Deliveries, n (%)
>=2
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Chorionicity, n (%)
Dichorionic
21 Participants
n=99 Participants
21 Participants
n=107 Participants
42 Participants
n=206 Participants
Chorionicity, n (%)
Monochorionic-Diamniotic
12 Participants
n=99 Participants
12 Participants
n=107 Participants
24 Participants
n=206 Participants
Maternal BMI (kg/m2), mean, SD
30.0 kg/m^2
STANDARD_DEVIATION 5.7 • n=99 Participants
30.5 kg/m^2
STANDARD_DEVIATION 7.3 • n=107 Participants
30.25 kg/m^2
STANDARD_DEVIATION 6.5 • n=206 Participants
Tobacco use in pregnancy, n (%)
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Gestational diabetes mellitus, n (%)
5 Participants
n=99 Participants
6 Participants
n=107 Participants
11 Participants
n=206 Participants
Preoperative maternal hemoglobin level (g/dL), mean (SD)
11.6 g/dL
STANDARD_DEVIATION 1.2 • n=99 Participants
12.0 g/dL
STANDARD_DEVIATION 1.3 • n=107 Participants
11.8 g/dL
STANDARD_DEVIATION 1.25 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline and Postoperative Day 1 (Approximately 48 hours)

The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Change in Maternal Hemoglobin Level
1.1 g/dL
Standard Deviation 0.7
2.1 g/dL
Standard Deviation 0.9

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Surgical time measured from the time of incision to closure

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Surgical Time
62.0 Minutes
Interval 54.0 to 75.0
61.0 Minutes
Interval 49.0 to 69.0

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

At the end of the surgery, the primary surgeon will estimate the blood loss throughout the case.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Estimated Blood Loss
800 cc
Interval 800.0 to 900.0
1000 cc
Interval 800.0 to 1098.0

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Quantitative blood loss is calculated by weighing the used towels during the operation. The number is calculated by the circulating nurse in the operating room.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Quantitative Blood Loss
891 cc
Interval 743.0 to 966.0
1017 cc
Interval 931.0 to 1211.0

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

The number of participants with postpartum hemorrhage (defined as estimated blood loss \>1000 cc)

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants With Postpartum Hemorrhage
6 Participants
18 Participants

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Number of participants given uterotonics, such as prostaglandins

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants Requiring Use of Uterotonics
0 Participants
6 Participants

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Number of participants given Tranexamic acid

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants Requiring Use of Tranexamic Acid
2 Participants
7 Participants

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Number of participants requiring the use of any amount of open-label methylergonovine (not blinded study drug)

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants Requiring Use of Open-Label Methylergonovine
0 Participants
7 Participants

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Number of participants requiring transfusion of 1 or more units of packed red blood cells, including whole blood or cell saver.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants Requiring Transfusion (Intraoperative)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Intraoperative (Approximately 24 hours)

Composite number of surgical or radiological interventions (such as: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology) to control bleeding and related complications or maternal death.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants With Surgical or Radiological Interventions
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants with transfusion related acute lung injury (TRALI)

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants With Transfusion Related Acute Lung Injury (TRALI)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants requiring transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants Requiring Transfusion (6 Weeks)
2 Participants
4 Participants

SECONDARY outcome

Timeframe: 48 hours

Number of participants with acute elevation of serum creatinine of ≥ 0.3 mg/dL

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants With Acute Elevation of Serum Creatinine
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of Postpartum infectious complications such as: endometritis, surgical site infection, pelvic abscess

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Postpartum Infectious Complications
0 Participants
2 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants with admission to the intensive care unit for more than 24 hours

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants With Admission to the Intensive Care Unit
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Length of stay measured from the time of hospital admission to hospital discharge.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Length of Stay
4 days
Interval 3.0 to 4.0
4 days
Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: 6 weeks

The number of participants who experienced hospital re-admission

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=33 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=33 Participants
Normal Saline 1mL
Number of Participants Re-Admitted to the Hospital
1 Participants
3 Participants

SECONDARY outcome

Timeframe: 1 and 5 minutes post-delivery (approximately 24 hours post-baseline)

Population: Newborns were assessed rather than the mothers (i.e. enrolled participants). Each participant gave birth to twins (66 newborns total). Newborns were not considered enrolled but did contribute to this assessment.

Apgar score is a measure of the physical condition of a newborn infant. Scores range from 0-10 with a higher score indicating a better outcome; Apgar score of 0-3 is low, 4-6 is moderately abnormal, and 7-10 is reassuring.

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=66 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=66 Participants
Normal Saline 1mL
Apgar Scores
Apgar 5 minutes
9 score on a scale
Interval 9.0 to 9.0
9 score on a scale
Interval 9.0 to 9.0
Apgar Scores
Apgar 1 minute
8 score on a scale
Interval 8.0 to 9.0
8 score on a scale
Interval 8.0 to 8.0

SECONDARY outcome

Timeframe: Time of delivery (Approximately 24 hours)

Population: Newborns were assessed rather than the mothers (i.e. enrolled participants). Each participant gave birth to twins (66 newborns total). Newborns were not considered enrolled but did contribute to this assessment.

Number of newborns admitted to the neonatal intensive care unit (NICU).

Outcome measures

Outcome measures
Measure
Prophylactic Methylergonovine
n=66 Participants
Prophylactic methylergonovine 200mcg IM
Placebo Group
n=66 Participants
Normal Saline 1mL
Neonatal Intensive Care Unit (NICU) Admission
19 newborns
20 newborns

Adverse Events

Prophylactic Methylergonovine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Intramuscular Methylergonovine to Decrease Blood Loss During Cesarean Delivery for Twins: A Triple-B

NewYork-Presbyterian Hospital, Columbia University Irving Medical Center

Phone: 877-843-2229

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place