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Uterine Stimulant

Methylergonovine for Postpartum Hemorrhage

Phase 4

Recruiting

Led By Mirella Mourad

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and postoperative day 1 (approximately 48 hours)

Awards & highlights

Study Summary

This trial is studying if a drug can reduce bleeding in twin pregnancy cesarean deliveries. Participants randomly get the drug or a placebo.

Who is the study for?

This trial is for women with twin pregnancies scheduled for a cesarean delivery at or beyond 34 weeks. It's not suitable for those with hypertension, on protease inhibitors, allergic to methylergonovine, involved in other bleeding-related studies, or expecting non-elective cesarean delivery.Check my eligibility

What is being tested?

The study aims to see if giving methylergonovine right after delivering twins by cesarean can reduce blood loss compared to a placebo (saltwater). Participants will be randomly assigned to receive either the drug or placebo as an injection post-delivery.See study design

What are the potential side effects?

Methylergonovine may cause side effects such as increased blood pressure and nausea. Since it's given immediately after childbirth when monitoring is intense, any adverse reactions can be quickly managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and postoperative day 1 (approximately 48 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and postoperative day 1 (approximately 48 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and postoperative day 1 (approximately 48 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in maternal hemoglobin level

Secondary outcome measures

Apgar scores

Composite Number of Surgical or Radiological Interventions

Estimated blood loss

+15 more

Side effects data

From 2021 Phase 4 trial • 160 Patients • NCT03904446

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Methylergonovine 0.2 mg

Placebo (Normal Saline)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Prophylactic methylergonovineExperimental Treatment1 Intervention

Prophylactic methylergonovine 200mcg IM

Group II: Control group/placeboPlacebo Group1 Intervention

Matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylergonovine

2019

Completed Phase 4

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,767 Total Patients Enrolled

Mirella MouradPrincipal InvestigatorColumbia University

Media Library

Methylergonovine (Uterine Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05772156 — Phase 4

Twin Pregnancy Research Study Groups: Prophylactic methylergonovine, Control group/placebo

Twin Pregnancy Clinical Trial 2023: Methylergonovine Highlights & Side Effects. Trial Name: NCT05772156 — Phase 4

Methylergonovine (Uterine Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05772156 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does prophylactic methylergonovine pose a hazard to patients?

"After careful consideration, our team has rated the safety profile of Prophylactic methylergonovine as a 3. This is due to its approval by the FDA in Phase 4 trials."

Answered by AI

Is there still room for participants in this research endeavor?

"As confirmed on the clinicaltrials.gov website, this medical trial is no longer recruiting individuals; it first posted on March 14th 2023 and was last updated a week prior, on March 6th 2023. Nevertheless, there are still 410 other studies actively seeking patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic Methylergonovine for Twin Cesarean

Mirella Mourad 2023. "Prophylactic Methylergonovine for Twin Cesarean". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05772156.