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.
None
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
Single group
Cervical ripening, labor Induction, uterus and fetal monitoring
DeviceINGA 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.
Proportion of successful sensor measurements
Proportion (%) of successful sensor measurements out of all measurement attempts. A successful measurement is defined as a sensor reading that provides clinically interpretable fetal heart rate and/or uterine contraction data for at least 10 consecutive minutes.
Healthcare professionals' experience of device usability
Composite healthcare professional-reported assessment of catheter and sensor usability, collected immediately after catheter and sensor placement using a structured study-specific questionnaire. Assessments include: Ease of catheter placement; Likert Scale (1=very difficult, 5=very easy; higher scores indicate easier placement) Catheter usability and balloon inflation; Likert Scale (1=poor, 5=excellent; higher scores indicate better usability) Sensor attachment and stability; Likert Scale (1=poor, 5=excellent; higher scores indicate better performance) Technical performance of the sensor, including connection to bluetooth and battery life; Likert Scale (1=poor, 5= excellent; higher scores indicate better performance) Impact on workflow and patient comfort; Likert Scale (1=strongly disagree, 5 = strongly agree; higher scores indicate greater agreement with the statement) Willingness to recommend future use (Yes/No)
Patient Experience of Device Use
Composite patient-reported assessment of pain, comfort, satisfaction, and overall experience collected 30 minutes after catheter insertion and sensor placement using a structured questionnaire. Pain is assessed using a 0-10 Numeric Rating Scale (0 = no pain, 10 = worst possible pain; higher = greater pain), including tolerability (yes/no), characteristics (sharp, burning, stabbing, throbbing, cramping, pressure, other), duration (brief moment, few minutes, longer than 30 minutes, other), and location (abdominal area, back, vagina, external genitals, other). Catheter and sensor usability, ease of placement, sensor attachment and stability, technical performance (tablet/Bluetooth connection, battery), impact on daily activities, and willingness to use in the future are assessed using Likert scales (1-5; higher = better). Discomfort or additional concerns may be recorded with optional comments.
Adverse Events and Safety
Incidence and type of maternal and fetal adverse events occurring during device use and labor induction. All adverse events are recorded and assessed according to clinical criteria.
Signal Quality Assessment
Assessment of maternal and fetal data signal quality, if data are available.
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Aalto University
Lead sponsor
University of Mississippi Medical Center
Collaborator
University of Minnesota
Collaborator
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