RECRUITING

Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.

Official Title

Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial

Quick Facts

Study Start:2023-04-13
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05759988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lisa Levine, MD, MSCE
CONTACT
215-283-7373
lisa.levine@pennmedicine.upenn.edu
Meaghan McCabe, MPH
CONTACT
215-283-7373
meaghan.mccabe@pennmedicine.upenn.edu

Principal Investigator

Lisa Levine, MD, MSCE
PRINCIPAL_INVESTIGATOR
University of Pennsylvaina
Alison Cahill, MD, MSCI
PRINCIPAL_INVESTIGATOR
University of Texas at Austin

Study Locations (Sites)

Christiana Care Health Services, Inc.
Newark, Delaware, 19718
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Texas at Austin
Austin, Texas, 78712
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Lisa Levine, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvaina
  • Alison Cahill, MD, MSCI, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-04-13
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Foley balloon catheter
  • Outpatient cervical ripening

Additional Relevant MeSH Terms

  • Induction of Labor Affected Fetus / Newborn