Induced LaborINGA-SENPeNCT07846111
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
A study testing Cervical ripening, labor Induction, uterus and fetal monitoring in people with Induced Labor and Cervical Ripening, run by Aalto University at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 56 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Labor, Cervical Ripening, Cervical Ripening and Induction of Labor
- What is being tested?
- Cervical ripening, labor Induction, uterus and fetal monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEstonia
- Study dates
- Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- Condition of the fetus or mother requiring immediate delivery
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia1 site
West-Tallinn Central Hospital Women's Clinic (AS Lääne-Tallinna Keskhaigla naistekliinik/Pelgulinna Sünnitusmaja)
Tallinn, 10614
Ksenia Buts, MD, +372 666 5705, ksenia.buts@keskhaigla.ee
About this study
Official title: Medical Device Pilot Study on the Safety and Feasibility 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Induced Labor, Cervical Ripening, Cervical Ripening and Induction of Labor, Balloon Catheter for Labor Induction
- Being tested
- Cervical ripening, labor Induction, uterus and fetal monitoring
- Keywords
- Cervical ripening, Induction of labor, Balloon catheter, Fetal monitoring, Uterine monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ripening, labor Induction, uterus and fetal monitoringDevice
INGA 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cervical ripening, labor Induction, uterus and fetal monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During catheter and sensor placement, up to 24 hours
Secondary outcomes (14)
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)
Measured: Periprocedurally
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.
Measured: Periprocedurally
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.
Measured: Periprocedurally (after catheter and sensor placement)
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.
Measured: Periprocedurally (after catheter and sensor placement)
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. Adverse events are collected from the start of labor induction until discharge from the hospital after delivery.
Measured: Through study completion, an average of 4 days.
Percentage of monitoring time with valid continuous pressure signal from the INGA Sensor
Signal quality will be assessed from the continuous pressure signal recorded by the INGA Sensor. A valid signal is defined as pressure data meeting the predefined signal validity criteria specified for the INGA Sensor. The outcome will be calculated as the duration of valid continuous pressure signal divided by the total monitoring duration and multiplied by 100.
Unit of Measure: Percentage of monitoring time
Measured: During continuous monitoring from INGA catheter and INGA sensor placement until catheter expulsion and sensor removal, up to 24 hours
Device malfunctions
Number and type of device malfunctions occurring during catheter and sensor placement. Unit of Measure = count of malfunctions
Measured: During catheter and sensor placement, up to 24 hours
Signal Interruptions
Number and cumulative temporal duration of INGA sensor pressure signal interruptions during the recordings. Unit of Measure: Number of interruption events and length of signal interruption periods in minutes.
Measured: During continuous monitoring with the INGA Sensor, from sensor placement until sensor removal, up to 24 hours
Time required for setup and measurement
Time required for device setup and initiation of successful measurement
Measured: Periprocedurally, from the start of catheter placement to the initiation of successful sensor measurement, up to 120 minutes
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.
Measured: From catheter insertion to detachment, assessed up to 24 hours.
Placement success
Whether the catheter is placed successfully
Measured: Periprocedurally, at the time of catheter insertion, up to 30 minutes
Retention time of balloon catheter
Time the balloon catheter remains in the cervix for cervical ripening
Measured: 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
Measured: 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
Measured: From time of enrollment until delivery, assessed up to 7 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Collaborators
- West Tallinn Central Hospital
- Responsible party
- Sponsor
- Investigators
- Leena Rahkonen, MD, PhD, Associate professor, Study chair, Aalto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846111
- Sponsor's protocol ID
- CIV-EE-26-08-059575.
- Other IDs
- 240023
- Acronym
- INGA-SENPe
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Device Pilot Study on the Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening With the INGA Balloon Catheter
- ClinicalTrials.gov ID
- NCT07846111
- Acronym / sponsor ID
- INGA-SENPe / CIV-EE-26-08-059575.
- Conditions
- Induced Labor, Cervical Ripening, Cervical Ripening and Induction of Labor, Balloon Catheter for Labor Induction
- Keywords
- Cervical ripening, Induction of labor, Balloon catheter, Fetal monitoring, Uterine monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Collaborators
- West Tallinn Central Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INGA Sensor | Experimental | Device: Cervical ripening, labor Induction, uterus and fetal monitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical ripening, labor Induction, uterus and fetal monitoringINGA 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. | Device | INGA Sensor |
Primary outcome
Proportion of successful sensor measurements
Time frame: During catheter and sensor placement, up to 24 hours
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.
14 secondary outcomes
Patient-reported assessment of pain
Time frame: Periprocedurally
Patient-reported experience of the device use
Time frame: Periprocedurally
Healthcare professionals' experience of catheter usability
Time frame: Periprocedurally (after catheter and sensor placement)
Health care professional's experience on the sensor usability
Time frame: Periprocedurally (after catheter and sensor placement)
Adverse events and safety
Time frame: Through study completion, an average of 4 days.
Percentage of monitoring time with valid continuous pressure signal from the INGA Sensor
Time frame: During continuous monitoring from INGA catheter and INGA sensor placement until catheter expulsion and sensor removal, up to 24 hours
Device malfunctions
Time frame: During catheter and sensor placement, up to 24 hours
Signal Interruptions
Time frame: During continuous monitoring with the INGA Sensor, from sensor placement until sensor removal, up to 24 hours
Time required for setup and measurement
Time frame: Periprocedurally, from the start of catheter placement to the initiation of successful sensor measurement, up to 120 minutes
Bishop score change
Time frame: From catheter insertion to detachment, assessed up to 24 hours.
Placement success
Time frame: Periprocedurally, at the time of catheter insertion, up to 30 minutes
Retention time of balloon catheter
Time frame: From catheter insertion to detachment, 0-24 hours
Induction to delivery Interval
Time frame: From balloon catheter placement to birth, 0-48 hours
Mode of delivery
Time frame: From time of enrollment until delivery, assessed up to 7 days from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leena Rahkonen, MD, PhD, Associate professor study chair
Aalto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical ripening, labor Induction, uterus and fetal monitoring in people with Induced Labor and Cervical Ripening, run by Aalto University at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alena Lokteva (+358413100927, alena@mdsfinland.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of successful sensor measurements (time frame: During catheter and sensor placement, up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.