RECRUITING

Outpatient Transcervical Balloon For Induction of Labor

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

The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are: 1. Does outpatient transcervical foley balloon decreased the time from admission to delivery compared to inpatient vaginal misoprostol 2. Does outpatient transcervical foley balloon will increase risk of c-section during induction of labor compared to inpatient vaginal misoprostol Participants will be randomized to either the outpatient transcervical foley balloon group or to the inpatient intravaginal misoprostol group. The researchers will compare if outpatient transcervical foley balloon decreases the tie from hospital admission to delivery of the baby.

Official Title

Outpatient Transcervical Balloon: Does it Shorten the Hospital Stay for Induction of Labor? Randomized Control Trial

Quick Facts

Study Start:2022-06-09
Study Completion:2023-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05798728

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 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Term singleton pregnancy (37 weeks of gestation or greater)
  2. 2. Bishop score less than 6 and a maximum cervical dilation of 2 cm
  3. 3. Cephalic presentation
  1. 1. Rupture of membranes
  2. 2. Regular uterine contractions (3 or more contractions per 10 minutes)
  3. 3. History of prior uterine surgery (cesarean delivery or myomectomy)
  4. 4. Multiples gestations
  5. 5. Malpresentation
  6. 6. Nonreassuring fetal heart tracing (category 3 or persistent category 2)
  7. 7. Fetal demise
  8. 8. Anomalous fetus
  9. 9. Any contraindication to vaginal delivery

Contacts and Locations

Study Contact

Barouyr Ajemian, MD
CONTACT
810-262-6862
bajemia1@hurleymc.com

Principal Investigator

Atinuke Akinpeloye, MD
PRINCIPAL_INVESTIGATOR
Hurley Medical Canter

Study Locations (Sites)

Hurley Medical Center
Flint, Michigan, 48503
United States

Collaborators and Investigators

Sponsor: Hurley Medical Center

  • Atinuke Akinpeloye, MD, PRINCIPAL_INVESTIGATOR, Hurley Medical Canter

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 Date2022-06-09
Study Completion Date2023-10-01

Study Record Updates

Study Start Date2022-06-09
Study Completion Date2023-10-01

Terms related to this study

Keywords Provided by Researchers

  • Misoprostol
  • Cytotec
  • Cervical ripening
  • Outpatient
  • Inpatient
  • Transcervical foley balloon
  • Mechanical dilation

Additional Relevant MeSH Terms

  • Induced Vaginal Delivery
  • Induced; Birth