Trial Outcomes & Findings for Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients (NCT NCT03904446)

NCT ID: NCT03904446

Last Updated: 2022-08-01

Results Overview

Categorical Variable (Yes/No) - Depending on whether patients required additional uterotonic agents the outcome measure will be yes or no.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 160 participants
• Primary outcome timeframe: Assessed from the time of cesarean section until 24 hours postdelivery
• Results posted on: 2022-08-01

Participant Flow

Participant milestones

Measure	Methylergonovine 0.2 mg Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
Overall Study STARTED	80	80
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Methylergonovine 0.2 mg n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=80 Participants	80 Participants n=80 Participants	160 Participants n=160 Participants
Age, Categorical >=65 years	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=160 Participants
Sex: Female, Male Female	80 Participants n=80 Participants	80 Participants n=80 Participants	160 Participants n=160 Participants
Sex: Female, Male Male	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	80 participants n=80 Participants	80 participants n=80 Participants	160 participants n=160 Participants

PRIMARY outcome

Timeframe: Assessed from the time of cesarean section until 24 hours postdelivery

Categorical Variable (Yes/No) - Depending on whether patients required additional uterotonic agents the outcome measure will be yes or no.

Outcome measures

Measure	Methylergonovine 0.2 mg n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol)	80 Participants	80 Participants

SECONDARY outcome

Timeframe: Quantitative Blood Loss is measured at the completion of the cesarean delivery, an average of 2 hours

As per protocol, nurses will measure the quantitative blood loss by measuring the blood in the canisters used during the cesarean section and by weighing the sponges used in the surgery.

Outcome measures

Measure	Methylergonovine 0.2 mg n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
Quantitative Blood Loss	967 mL Standard Deviation 429	1315 mL Standard Deviation 915

SECONDARY outcome

Timeframe: Preoperative hemoglobin level is collected on arrival to labor and delivery prior to the cesarean section, postoperative hemoglobin is collected on postoperative day one.

As per standard protocol, preoperative and postoperative day one hemoglobin levels will be evaluated. the difference between the preoperative and postoperative day 1 hemoglobin values will be calculated.

Outcome measures

Measure	Methylergonovine 0.2 mg n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
The Difference Between the Preoperative and Postoperative (Postpartum Day 1) Hemoglobin Values	2.36 g/dL Standard Deviation 1.08	2.91 g/dL Standard Deviation 1.08

SECONDARY outcome

Timeframe: Obstetricians will assess the uterine tone 4 minutes following delivery of the infant

Nursing will notify the obstetrical provider 4 minutes following delivery of the infant and the obstetrical provider will determine whether the uterine tone is noted to be satisfactory (uterus is contracted) or unsatisfactory (uterus boggy)

Outcome measures

Measure	Methylergonovine 0.2 mg n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
Number of Patients With Unsatisfactory Uterine Tone 4 Min Following Delivery as Assessed by the Obstetrician	64 Participants	33 Participants

SECONDARY outcome

Timeframe: The need for a blood transfusion during the cesarean section up until hospital discharge (which is typically postpartum day number 3 for patients undergoing cesarean delivery)

The number of patients who required a blood transfusion

Outcome measures

Measure	Methylergonovine 0.2 mg n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 Participants Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
The Number of Patients Who Required a Blood Transfusion During the Delivery Hospitalization	4 Participants	18 Participants

Adverse Events

Methylergonovine 0.2 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo (Normal Saline)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Methylergonovine 0.2 mg n=80 participants at risk Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.	Placebo (Normal Saline) n=80 participants at risk Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular Normal Saline (placebo): 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
Pregnancy, puerperium and perinatal conditions Hypertension	8.8% 7/80 • Number of events 7 • During delivery hospitalization (approximately 3-6 days) Hypertension (defined as blood pressure \> 160/110 mmHg)	11.2% 9/80 • Number of events 9 • During delivery hospitalization (approximately 3-6 days) Hypertension (defined as blood pressure \> 160/110 mmHg)

Additional Information

Cynthia A. Wong, MD

University of Iowa

Phone: 13193563868

Email: cynthia-wong@uiowa.edu

Results disclosure agreements

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