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

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.

Conditions

• Induction of Birth
• Cervical Ripening
• Cervical Ripening and Induction of Labor
• Balloon Catheter for Labor Induction

Interventions

DEVICE

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.

Sponsors & Collaborators

• University of Mississippi Medical Center

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Aalto University

  lead OTHER

Principal Investigators

• Leena Rahkonen, MD, PhD, Associate professor · Aalto University

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

56 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2026-09-30

Completion

2027-05-01

FDA Device

Yes