Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening

The goal of this clinical trial is to learn about the safety and performance of the INGA Sensor System when used with the INGA balloon catheter during cervical ripening for labor induction in pregnant individuals at term. Cervical ripening is a process used to prepare the cervix for labor. The main questions it aims to answer are: * Is the INGA Sensor System safe to use during cervical ripening with the INGA balloon catheter? * How well does the sensor system measure uterine contractions and fetal heart rate during cervical ripening? * How does the use of the INGA balloon catheter affect cervical ripening and the time from induction to delivery? * How do participants and healthcare professionals evaluate the usability of the catheter and sensor system? All participants in this study will receive the INGA balloon catheter with the attached sensor system. There is no comparison group. Participants will: * Undergo routine assessments before labor induction, including medical history review, cervical examination, blood pressure and heart rate measurement, and fetal heart rate monitoring * Have the INGA balloon catheter placed in the cervix by a trained physician * Have a small sensor device attached to the external end of the catheter * Undergo standard fetal heart rate monitoring after placement * Keep the catheter and sensor in place until the catheter is expelled naturally or for up to 24 hours * Continue labor induction and delivery according to standard hospital practice * Complete a questionnaire about comfort and usability * Allow collection of information about labor, delivery, and newborn outcomes from medical records Participation lasts from signing informed consent until hospital discharge.

NCT Number	NCT07432282
Lead Sponsor	Aalto University Collaborators: University of Mississippi Medical Center, University of Minnesota
Conditions	Induction of Birth, Cervical Ripening, Cervical Ripening and Induction of Labor, Balloon Catheter for Labor Induction
Enrollment	120 participants
Start Date	2026-08-01
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-22