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Prostaglandin Analog

Pitocin only for Childbirth

Phase 3

Waitlist Available

Led By Angela Bianco, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Pregnant patient presenting to labor & delivery for induction of labor with a BMI >= 30

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of induction until delivery

Awards & highlights

Study Summary

This trial is testing whether using either misoprostol or pitocin along with a foley catheter is better at starting labor in pregnant patients with a high BMI.

Who is the study for?

This trial is for pregnant individuals with a BMI of 30 or higher who are going to the hospital to start labor. It's not for those with a BMI under 30.Check my eligibility

What is being tested?

The study is testing if using Misoprostol and Pitocin together, along with a foley catheter, is better at starting labor compared to just Pitocin and the catheter in patients considered obese.See study design

What are the potential side effects?

Misoprostol may cause cramping, nausea, diarrhea, or fever. Pitocin can lead to strong contractions which might stress the baby or cause changes in fetal heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant, have a BMI of 30 or more, and am going to be induced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time from induction to delivery

Secondary outcome measures

Delivery outcome

Trial Design

2Treatment groups

Active Control

Group I: Pitocin onlyActive Control1 Intervention

Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

Group II: Misoprostol and PitocinActive Control1 Intervention

Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

524,976 Total Patients Enrolled

Angela Bianco, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

3 Previous Clinical Trials

979 Total Patients Enrolled

Nicola F Tavella, MPHStudy DirectorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for patient participation in this clinical trial?

"As per clinicaltrials.gov, this specific research study is not presently seeking participants. The trial's initial posting was on May 1st, 2024, with the latest update made on February 6th, 2024. While this particular trial is inactive in terms of recruitment, it's noteworthy that there are currently 83 other trials actively seeking eligible candidates for participation."

Answered by AI

Do the FDA allow Misoprostol and Pitocin for medical use?

"Our team at Power has assigned a safety rating of 3 to Misoprostol and Pitocin as part of this Phase 3 trial, reflecting the availability of efficacy data along with extensive safety evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Different Medications to Induce Labor

Angela Bianco 2024. "Different Medications to Induce Labor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06259097.

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