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Outpatient for Induced Birth

N/A
Waitlist Available
Led By Katherine Kohari, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation)
Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor Cervical exam with Bishop Score <6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days of foley placement
Awards & highlights

Study Summary

This trial is comparing how effective and safe it is to induce labor by transcervical Foley catheter in a hospital setting versus outside of a hospital setting.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from labor induction to delivery time
This trial's timeline: 3 weeks for screening, Varies for treatment, and from labor induction to delivery time 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 of Foley catheter extrusion
Secondary outcome measures
APGAR scores
Analgesia used during pre-induction
Bishop score
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Outpatients with a transcervical Foley catheterExperimental Treatment1 Intervention
Women with a transcervical Foley catheter in place that will spend the night at home.
Group II: Inpatients with a transcervical Foley catheterActive Control1 Intervention
Women to be admitted to the hospital overnight which has been a "standard of care".
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Outpatient
2015
N/A
~1060

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,359 Total Patients Enrolled
Katherine Kohari, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials

Frequently Asked Questions

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

How many patients are participating in this clinical experiment?

"Affirmative. The information on clinicaltrials.gov ascertains that this research trial, first publicized on the 8th of January 2019 is still actively recruiting volunteers. 400 individuals are required to be recruited from 2 separate facilities for this study."

Answered by AI

Is there available enrollment capacity for this clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this experiment is actively recruiting participants as of May 19th 2022; it was initially posted in August 1st 2019. In total, 400 test subjects need to be enrolled from two distinct medical centres."

Answered by AI
~9 spots leftby Mar 2025