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

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

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.

This is a prospective, single-arm, early feasibility clinical trial designed to evaluate the safety, performance, and usability of the INGA Sensor System when used together with the INGA cervical ripening catheter during induction of labor in pregnant individuals at term. Approximately 120 participants are planned to be enrolled.

The primary objective of the study is to evaluate the performance of the INGA Sensor System in providing clinically interpretable data on fetal wellbeing and induction progress during cervical ripening. A successful measurement is defined as the sensor providing interpretable signal data for at least 10 consecutive minutes.

Secondary objectives include evaluation of device usability, technical performance, maternal and neonatal safety, and obstetric outcomes such as change in Bishop score, induction-to-delivery interval, and mode of delivery.

Participation lasts from signing informed consent until hospital discharge following delivery.

Screening phase

Before any study-related procedures are initiated, participants will be asked to read and sign an informed consent form. Once consent has been obtained, the following screening assessments will be performed to determine eligibility:

• Confirmation of informed consent.
• Review of inclusion and exclusion criteria to confirm suitability for the study.
• Collection of medical and demographic data, including medical history, current or previous medications, planned time of delivery, gestational age, and indication for labor induction.
• Cervical assessment by palpation.
• Measurement of blood pressure and heart rate.
• Cardiotocography (CTG) to monitor fetal heart rate and uterine contractions for at least 30 minutes.
• Ultrasound examination within one week prior to labor induction to assess fetal weight, well-being, and general condition.

Participants who meet all eligibility criteria will proceed to the study phase.

The study follows the standard clinical process for balloon catheter-based cervical ripening, with the addition of the investigational sensor. After insertion of the INGA catheter, the study sensor will be attached to the external end of the catheter fixed to the thigh for the duration of catheter placement. The sensor records data that are not visible to the participant or healthcare professionals. Throughout the procedure, the investigator and hospital staff will closely monitor the induction process and ensure the safety and well-being of both the mother and fetus.

Study procedures

Participants will undergo the following procedures as part of the study:

• A trained physician will insert the INGA cervical ripening catheter vaginally through the cervical canal. The balloon will be inflated with sterile saline to secure placement and taped to the inner thigh according to standard practice. After catheter placement, the INGA Sensor will be attached to the external portion of the catheter.
• Fetal heart rate monitoring (CTG) will be performed both before catheter insertion (for a minimum of 30 minutes) and after insertion (for a minimum of 60 minutes). After that, the sensor remains in place and continues to record data until it is turned off. Subsequent CTG monitoring during labor induction is conducted in accordance with the hospitals or clinic's protocol and guidelines
• Cervical ripeness will be assessed before catheter insertion and again after catheter removal or spontaneous detachment.
• The catheter will remain in place until it detaches spontaneously or for a maximum of 24 hours.
• After catheter removal, the cervical status will be reassessed, and labor induction will continue according to the hospital's standard of care.

Throughout the induction process, maternal and fetal well-being will be closely monitored by clinical staff. All adverse events and device-related events will be recorded and evaluated.

Comprehensive data will be collected on:

• The course of pregnancy and the labor induction process.
• Delivery outcomes, including mode and duration of delivery.
• Maternal safety data, including any adverse events or complications.
• Newborn assessments
• After birth, the following assessments will be performed on the newborn:
• Birth weight and height.
• Apgar score at 5 minutes after birth.
• Clinical data related to neonatal diagnoses, treatments, or conditions.

The sensor data will be analyzed by the sponsor's research team.

Questionnaires

To evaluate user experience and device tolerability, the following questionnaires will be completed:

Participants will be asked to complete a short questionnaire assessing their overall comfort, well-being, and any discomfort or pain experienced during balloon catheter placement and use.

The physician who inserted the catheter will complete a usability questionnaire assessing the practicality, ease of use, and overall handling of the device.

Post-Treatment Phase The INGA catheter and sensor are used only during the induction process in this study. No additional study-specific visits are required after hospital discharge. Postpartum care will follow standard hospital practice.

Inclusion Criteria:

Pregnant women aged ≥18 and ≤56 years An unripe cervix, see below Planned induction of labor by mechanical balloon catheter method Gestational age at the time of the study ≥ 37 weeks Singleton pregnancy Cephalic presentation The subject understands the study information and signs the informed consent

Exclusion Criteria:

• Preterm induction of labor (<37 weeks of gestation)
• Clinical active vaginal or uterine infection
• Abnormal cardiotocography (CTG) at inclusion
• Spontaneous rupture of membranes at inclusion
• Clinically significant vaginal bleeding with need of hospitalization in the third trimester
• Maternal HIV, hepatitis C, or hepatitis B
• Condition requiring immediate delivery of the fetus or mother
• Presence of eclampsia
• Severe Preeclampsia (Blood pressure ≥160/110 and any of the following: HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelet count <100 × 10 9/L syndrome), progressive renal insufficiency, pulmonary edema)
• Severe fetal growth restriction (FGR, growth < -2 SD/<10th percentile)
• Estimated fetal weight ≥ 2SD or ≥ 95th percentile
• Breech or transverse fetal position
• Multiple pregnancy
• Vasa previa or placenta previa
• Uterine scar (including previous caesarean section)
• Umbilical cord prolapse
• Bishop score ≥6 on cervical assessment prior to labor induction
• Reduced amniotic fluid volume (deepest vertical pocket <30 mm)
• Receiving epidural anesthesia prior to catheter insertion
• Refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form