Double Uterotonic Agents for Postpartum Hemorrhage

Phase 3

Recruiting

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Women under 18 years old

Women with known coagulation disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effects of two different medications given to prevent postpartum hemorrhage.

Who is the study for?

This trial is for women aged 18 or older giving birth at Stony Brook University hospital who consent to participate. It excludes those planning a cesarean hysterectomy, with placental accreta spectrum disorders, allergies to prostaglandins, coagulation disorders, or under 18.

What is being tested?

The study tests if using two drugs (IV Oxytocin and Sublingual Misoprostol) together is better than just one (Oxytocin alone) in preventing early postpartum hemorrhage. The effectiveness and side effects of the double versus single medication regimen are being compared.

What are the potential side effects?

Potential side effects may include reactions related to uterotonic agents such as nausea, vomiting, diarrhea, fever, shivering and heart rate changes. Specific side effects from combining these medications will be studied.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman under 18 years old.

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I have a known blood clotting disorder.

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I am allergic to prostaglandins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume.

Secondary study objectives

Determine serious adverse outcomes of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only) that is documented in the medical record.