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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
458 Previous Clinical Trials
470,748 Total Patients Enrolled
Brigid McCue, MDPrincipal InvestigatorNorthwell Health

Frequently Asked Questions

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

Is there an opportunity to participate in this investigation?

"Acceptance to this medical experiment necessitates that participants have gone through induction labour, and are aged between 18 and 40. Altogether, 300 people will be recruited for the study."

Answered by AI

Does this research project still have vacancies for participants?

"Confirmed, the clinical trial is still accepting participants. The first posting was on March 1st 2019 and most recently updated April 18th 2022; 300 patients are being sought from two sites."

Answered by AI

Does this trial have any age restrictions for potential participants?

"This research is seeking out adults aged 18 through 40 to participate."

Answered by AI

What is the total participant count for this clinical experiment?

"Correct. Clinicaltrials.gov confirms that this scientific research, which was first posted on March 1st 2019, is actively recruiting patients. Approximately 300 people should be recruited from two distinct sites."

Answered by AI
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
A Prospective Randomized Evaluation of a Hygroscopic Cervical Dilator, Dilapan, in the Preinduction Ripening of Patients Undergoing Induction of Labor
Gilson, George J., Debora J. Russell, Luis A. Izquierdo, Clifford R. Qualls, and Luis B. Curet. 1996. “A Prospective Randomized Evaluation of a Hygroscopic Cervical Dilator, Dilapan, in the Preinduction Ripening of Patients Undergoing Induction of Labor”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(96)70264-8.
Obstetrics & GynecologyJournal
Outpatient Foley Catheter for Induction of Labor in Parous Women
Kuper, Spencer G., Victoria C. Jauk, David M. George, Rodney K. Edwards, Jeff M. Szychowski, Sara E. Mazzoni, Michelle J. Wang, et al.. 2018. “Outpatient Foley Catheter for Induction of Labor in Parous Women”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002678.
Obstetrics & GynecologyJournal
Transcervical Foley Catheter for Preinduction Cervical Ripening in an Outpatient Versus Inpatient Setting
SCISCIONE, A. 2001. “Transcervical Foley Catheter for Preinduction Cervical Ripening in an Outpatient Versus Inpatient Setting”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(01)01579-4.
Plos OneJournal
Hygroscopic Dilators Vs Balloon Catheter Ripening of the Cervix for Induction of Labor in Nulliparous Women at Term: Retrospective Study
Shindo, Ryosuke, Shigeru Aoki, Naohiro Yonemoto, Yuriko Yamamoto, Junko Kasai, Michi Kasai, and Etsuko Miyagi. 2017. “Hygroscopic Dilators Vs Balloon Catheter Ripening of the Cervix for Induction of Labor in Nulliparous Women at Term: Retrospective Study”. Edited by Shannon M. Hawkins. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0189665.
~30 spots leftby Apr 2025
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