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Amniotomy for Labor Induction

N/A

Waitlist Available

Led By Marissa Berry, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

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 from admission to discharge, up to 2 weeks

Awards & highlights

Study Summary

This trial will assess whether earlier amniotomy (breaking the water) during labor induction leads to shorter labor overall, with no increase in c-section rates.

Eligible Conditions

Labor Induction
Early Amniotomy

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 to active phase of labor

Secondary outcome measures

Cesarean section rate

Maternal infection composite

Neonatal outcome composite

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early amniotomyExperimental Treatment2 Interventions

Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.

Group II: Delayed amniotomyActive Control2 Interventions

Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amniotomy

2021

N/A

~230

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

241 Previous Clinical Trials

56,441 Total Patients Enrolled

Marissa Berry, MDPrincipal InvestigatorUniversity of Texas

Frequently Asked Questions

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

Are there remaining vacancies for enrolment in this research project?

"Affirmative. The data hosted on clinicaltrials.gov shows that this medical trial, which was first listed on October 15th 2020, is actively recruiting volunteers. One hundred and seventy-four individuals must be recruited from a single site for the study to continue."

Answered by AI

What is the total population size of participants involved in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this research, initially uploaded on October 15th 2020, is currently recruiting participants. The study needs to find 174 subjects across 1 centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

2020. "Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04573517.