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| ID | Type | Description | Link |
|---|---|---|---|
| ARPA-H-ICHUB-24-101-1675/SWH-2 | Other Grant/Funding Number | ARPA-H |
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| Name | Class |
|---|---|
| University of Mississippi Medical Center | OTHER |
| University of Minnesota | OTHER |
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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:
All participants in this study will receive the INGA balloon catheter with the attached sensor system. There is no comparison group.
Participants will:
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:
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:
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INGA Sensor | Experimental | Participants in this single study arm will undergo cervical ripening using the INGA balloon catheter with the attached INGA sensor during labor induction. The catheter is inserted vaginally through the cervical canal so that the balloon tip is positioned between the amniotic membranes and the internal cervical os. The balloon is inflated with 50-75 mL of sterile saline and the external end is secured to the inner thigh. The INGA sensor is attached to the external portion of the catheter and records maternal and fetal data, such as heart rate and uterine contractions. Clinical monitoring is performed according to hospital guidelines. CTG monitoring is conducted for at least 60 minutes after placement. The sensor remains in place until catheter detachment or up to 24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical ripening, labor Induction, uterus and fetal monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During catheter and sensor placement, up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsi Roivainen, Master of Health | Contact | +358505347673 | kirsi.roivainen@mdsfinland.com | |
| Heidi Kruit, MD, PhD, Associate professor | Contact | +358504284685 | heidi.kruit@aalto.fi |
| Name | Affiliation | Role |
|---|---|---|
| Leena Rahkonen, MD, PhD, Associate professor | Aalto University | Study Chair |
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| Periprocedural (after catheter and sensor placement) |
| 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. | Immediately after catheter and sensor placement, before hospital discharge |
| 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. | rom catheter and sensor insertion until hospital discharge, with adverse events monitored for up to 24 hours after catheter removal or expulsion. |
| Signal Quality Assessment | Assessment of maternal and fetal data signal quality, if data are available. | During catheter and sensor placement, up to 24 hours |
| Device Malfunctions | Number and type of device malfunctions occurring during catheter and sensor placement. Unit of Measure = count of malfunctions | During catheter and sensor placement, up to 24 hours |
| Signal Interruptions | Number and duration of interruptions in fetal heart rate or uterine contraction signal during catheter and sensor placement. Unit of Measure: Number and minutes of signal interruptions | During catheter and sensor placement, up to 24 hours |
| Time Required for Setup and Measurement | Time required for device setup and initiation of successful measurement | At the time of catheter and sensor placement |
| Bishop score change | Change in cervical readiness measured by the Bishop Score, a 0-10 scale (0 = unfavorable cervix, 10 = fully favorable; higher scores indicate more favorable cervix), assessed prior to catheter insertion and after catheter detachment. | From catheter insertion to detachment, assessed up to 24 hours. |
| Placement success | Whether the catheter is placed successfully | At catheter insertion |
| Retention time of balloon catheter | Time the balloon catheter remains in the cervix for cervical ripening | From catheter insertion to detachment, 0-24 hours |
| Induction to delivery Interval | Time from initiation of labor induction (balloon catheter placement) to the delivery of the neonate. This includes both the cervical ripening phase and active labor. The outcome will capture the total duration of the induction-to-delivery process | From balloon catheter placement to birth, 0-48 hours |
| Mode of delivery | The type of delivery for the participant, categorized as vaginal delivery, instrumental vaginal delivery, or cesarean section | From time of enrollment until delivery, assessed up to 7 days from enrollment |
| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| D005323 | Fetal Monitoring |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008991 | Monitoring, Physiologic |
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