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.
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
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 balloon catheter mounted sensor system will be used for cervical ripening during labor induction. The data on sensor usability, registration of fetal and maternal heart activity, fetal movements and uterine contractions will be obtained. The 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 will be collected.
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.
Patient-reported assessment of pain
Patient-reported assessment of pain collected prior to, at insertion and 30 minutes after catheter insertion using a structured questionnaire. Pain is assessed using a 0-10 Numeric Rating Scale (0 = no pain, 10 = worst possible pain; higher = greater pain)
Patient-reported experience of the device use
Composite patient experience on integrated catheter and sensor system usability, ease of placement, sensor attachment and stability, technical performance, impact on daily activities, and willingness to use in the future are assessed using Likert scales (1-5; higher = better). The multiple Likert scale measurements will be aggregated to arrive at one reported Likert scale value as the overall integrated catheter and sensor system experience.
Healthcare professionals' experience of catheter usability
Composite healthcare professional-reported assessment of catheter usability, collected immediately after catheter 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; Likert Scale (1=poor, 5=excellent; higher scores indicate better usability), Balloon inflation; Likert Scale (1=poor, 5=excellent; higher scores indicate better usability). The multiple Likert scale measurements will be aggregated to arrive at one reported Likert scale value as the overall catheter usability.
Health care professional's experience on the sensor usability
Composite healthcare professional-reported assessment of sensor usability, collected immediately after the integrated sensor placement using a structured study-specific questionnaire. Assessments include: Sensor attachment; Likert Scale (1=poor, 5=excellent; higher scores indicate better performance), Sensor stability; Likert Scale (1=poor, 5=excellent; higher scores indicate better performance), Technical performance of the sensor; Likert Scale (1=poor, 5= excellent; higher scores indicate better performance), Impact on workflow; Likert Scale (1=strongly disagree, 5 = strongly agree; higher scores indicate greater agreement with the statement), Impact on patient comfort; Likert Scale (1=strongly disagree, 5 = strongly agree; higher scores indicate greater agreement with the statement). The multiple Likert scale measurements will be aggregated to arrive at one reported Likert scale value as the overall sensor usability.
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Aalto University
Lead sponsor
West Tallinn Central Hospital
Collaborator
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