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Device

Trans-cervical cervical balloon for Induction of Labour (CORC Trial)

N/A
Waitlist Available
Led By Brigid McCue, MD
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first hour
Awards & highlights

CORC Trial Summary

This trial is comparing two methods of inducing labor: one mechanical and one with medication.

CORC Trial Eligibility Criteria

Inclusion Criteria

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

CORC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~720-2160 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 720-2160 minutes 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 start of cervical ripening to delivery
Secondary outcome measures
Pain of insertion
Pain over duration of cervical ripening
Patient satisfaction with cervical ripening agent
Other outcome measures
10 minute Apgar score <7
Base excess >12
Composite score of adverse neonatal outcomes
+9 more

CORC Trial Design

2Treatment groups
Experimental Treatment
Group I: Trans-cervical cervical balloonExperimental Treatment1 Intervention
17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.
Group II: Hygroscopic cervical dilatorsExperimental Treatment1 Intervention
Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.

Find a Location

Who is running the clinical trial?

Ochsner Health SystemLead Sponsor
93 Previous Clinical Trials
184,476 Total Patients Enrolled
Northwell HealthOTHER
461 Previous Clinical Trials
470,950 Total Patients Enrolled
Brigid McCue, MDPrincipal InvestigatorNorthwell Health
~30 spots leftby Jun 2025
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