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Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Sponsor: Aalto University
Summary
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.
Official title: Early Feasibility Study on the Safety and Performance of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening With the INGA Balloon Catheter
Key Details
Gender
FEMALE
Age Range
18 Years - 56 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-05-01
Completion Date
2027-05-01
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Cervical ripening, labor Induction, uterus and fetal monitoring
INGA sensor with INGA Induction Catheter. The trial systematically collects data on sensor usability, registration of fetal and maternal heart activity and uterine contractions, INGA catheter insertion experience, patient pain, retention time, and delivery outcomes, as well as feedback from both participants and healthcare professionals regarding device performance and usability.