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Prostaglandin E1 Analog
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Misoprostol plus intravenous OxytocinExperimental Treatment2 Interventions
Patients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual
Group II: Intravenous Oxytocin onlyActive Control1 Intervention
Patients will receive standard postpartum Oxytocin IV per protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Misoprostol
FDA approved
Find a Location
Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
217 Previous Clinical Trials
38,628 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman under 18 years old.I have a known blood clotting disorder.I am a woman over 18, giving birth at Stony Brook University hospital and agree to join the study.You are a woman with a known condition called placental accreta spectrum disorders.I am allergic to prostaglandins.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous Oxytocin only
- Group 2: Misoprostol plus intravenous Oxytocin
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the government's official stance on IV Oxytocin?
"There is some evidence that IV Oxytocin is effective and it has undergone multiple rounds of testing, so it received a score of 3."
Answered by AI
Are we currently able to sign people up for this experiment?
"The clinical trial is actively recruiting patients, with the most recent update to the posting on clinicaltrials.gov being on February 16th, 2022. 1358 patients will be seen at a single location for this study."
Answered by AI
How many test subjects are needed for this clinical trial?
"That is correct. The information available on clinicaltrials.gov indicates that this trial, which was first advertised on March 1st 2022, is still recruiting patients. They are specifically looking for 1358 individuals from 1 medical facility to take part in the study."
Answered by AI
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