[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658011":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":73,"studyPopulation":67,"armGroups":74,"interventions":81,"overallOfficials":87,"centralContacts":91,"locations":101,"responsibleParty":119,"collaborators":121,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":67,"studyType":140,"phases":141,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":154,"whyStopped":67,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Aalto University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":67},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002For uterine contraction data for at least 10 consecutive minutes.","During catheter and sensor placement, up to 24 hours",[14,18,21,25,28,32,36,39,43,47,51,55,59,63],{"measure":15,"description":16,"timeFrame":17},"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)","Periprocedurally",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":24},"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.","Periprocedurally (after catheter and sensor placement)",{"measure":26,"description":27,"timeFrame":24},"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.",{"measure":29,"description":30,"timeFrame":31},"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.","Through study completion, an average of 4 days.",{"measure":33,"description":34,"timeFrame":35},"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.\n\nUnit of Measure: Percentage of monitoring time","During continuous monitoring from INGA catheter and INGA sensor placement until catheter expulsion and sensor removal, up to 24 hours",{"measure":37,"description":38,"timeFrame":12},"Device malfunctions","Number and type of device malfunctions occurring during catheter and sensor placement. Unit of Measure = count of malfunctions",{"measure":40,"description":41,"timeFrame":42},"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.","During continuous monitoring with the INGA Sensor, from sensor placement until sensor removal, up to 24 hours",{"measure":44,"description":45,"timeFrame":46},"Time required for setup and measurement","Time required for device setup and initiation of successful measurement","Periprocedurally, from the start of catheter placement to the initiation of successful sensor measurement, up to 120 minutes",{"measure":48,"description":49,"timeFrame":50},"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.",{"measure":52,"description":53,"timeFrame":54},"Placement success","Whether the catheter is placed successfully","Periprocedurally, at the time of catheter insertion, up to 30 minutes",{"measure":56,"description":57,"timeFrame":58},"Retention time of balloon catheter","Time the balloon catheter remains in the cervix for cervical ripening","From catheter insertion to detachment, 0-24 hours",{"measure":60,"description":61,"timeFrame":62},"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",{"measure":64,"description":65,"timeFrame":66},"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",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":67,"primaryPurpose":6,"observationalModel":67,"timePerspective":67,"maskingInfo":71},"NA","SINGLE_GROUP",{"masking":72,"maskingDescription":67,"whoMasked":67},"NONE","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.\n\nThe 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.\n\nSecondary 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.\n\nParticipation lasts from signing informed consent until hospital discharge following delivery.\n\nScreening phase\n\nBefore 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:\n\n* Confirmation of informed consent.\n* Review of inclusion and exclusion criteria to confirm suitability for the study.\n* Collection of medical and demographic data, including medical history, current or previous medications, planned time of delivery, gestational age, and indication for labor induction.\n* Cervical assessment by palpation.\n* Measurement of blood pressure and heart rate.\n* Cardiotocography (CTG) to monitor fetal heart rate and uterine contractions for at least 30 minutes.\n* Ultrasound examination within one week prior to labor induction to assess fetal weight, well-being, and general condition.\n\nParticipants who meet all eligibility criteria will proceed to the study phase.\n\nThe 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.\n\nStudy procedures\n\nParticipants will undergo the following procedures as part of the study:\n\n* 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.\n* 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\n* Cervical ripeness will be assessed before catheter insertion and again after catheter removal or spontaneous detachment.\n* The catheter will remain in place until it detaches spontaneously or for a maximum of 24 hours.\n* After catheter removal, the cervical status will be reassessed, and labor induction will continue according to the hospital's standard of care.\n\nThroughout 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.\n\nComprehensive data will be collected on:\n\n* The course of pregnancy and the labor induction process.\n* Delivery outcomes, including mode and duration of delivery.\n* Maternal safety data, including any adverse events or complications.\n* Newborn assessments\n* After birth, the following assessments will be performed on the newborn:\n* Birth weight and height.\n* Apgar score at 5 minutes after birth.\n* Clinical data related to neonatal diagnoses, treatments, or conditions.\n\nThe sensor data will be analyzed by the sponsor's research team.\n\nQuestionnaires\n\nTo evaluate user experience and device tolerability, the following questionnaires will be completed:\n\nParticipants 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.\n\nThe physician who inserted the catheter will complete a usability questionnaire assessing the practicality, ease of use, and overall handling of the device.\n\nPost-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.",[75],{"label":76,"type":77,"description":78,"interventionNames":79},"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.",[80],"Device: Cervical ripening, labor Induction, uterus and fetal monitoring",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":67},"DEVICE","Cervical ripening, labor Induction, uterus and fetal monitoring","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.",[76],[88],{"name":89,"affiliation":5,"role":90},"Leena Rahkonen, MD, PhD, Associate professor","STUDY_CHAIR",[92,97],{"name":93,"role":94,"phone":95,"phoneExt":67,"email":96},"Alena Lokteva","CONTACT","+358413100927","alena@mdsfinland.com",{"name":98,"role":94,"phone":99,"phoneExt":67,"email":100},"Heidi Kruit, MD, PhD, Associate professor","+358504284685","heidi.kruit@aalto.fi",[102],{"facility":103,"status":67,"city":104,"state":67,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"West-Tallinn Central Hospital Women's Clinic (AS Lääne-Tallinna Keskhaigla naistekliinik\u002FPelgulinna Sünnitusmaja)","Tallinn","10614","Estonia","EE",{"type":109,"coordinates":110},"Point",[111,112],24.75353,59.43696,{"lat":112,"lon":111},[115],{"name":116,"role":94,"phone":117,"phoneExt":67,"email":118},"Ksenia Buts, MD","+372 666 5705","ksenia.buts@keskhaigla.ee",{"type":120,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR",[122],{"name":123,"class":124},"West Tallinn Central Hospital","UNKNOWN","100658011","safety-and-feasibility-of-the-inga-sensor-system-for-fetal-and-uterine-monitoring-during-cervical-ripening-100658011",false,"NCT07846111","Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening","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","INGA-SENPe","Inclusion Criteria:\n\n* Pregnant women aged ≥18 and ≤56 years\n* An unripe cervix, see below\n* Planned induction of labor by mechanical balloon catheter method\n* Gestational age at the time of the study ≥ 37 weeks\n* Singleton pregnancy\n* Cephalic presentation\n* The subject understands the study information and signs the informed consent\n\nExclusion Criteria:\n\n* Preterm induction of labor (\\\u003C37 weeks of gestation)\n* Clinical active vaginal or uterine infection\n* Abnormal cardiotocography (CTG) at inclusion\n* Spontaneous rupture of membranes at inclusion\n* Clinically significant vaginal bleeding with need of hospitalization in the third trimester\n* Maternal HIV, hepatitis C, or hepatitis B\n* Condition of the fetus or mother requiring immediate delivery\n* Presence of eclampsia\n* Severe Preeclampsia (Blood pressure ≥160\u002F110 and any of the following: HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelet count \\\u003C100 × 10 9\u002FL syndrome), progressive renal insufficiency, pulmonary edema)\n* Severe fetal growth restriction (FGR, growth \\\u003C -2 SD\u002F\\\u003C10th percentile)\n* Estimated fetal weight ≥ 2SD or ≥ 95th percentile\n* Breech or transverse fetal position\n* Multiple pregnancy\n* Vasa previa or placenta previa\n* Uterine scar (including previous caesarean section)\n* Umbilical cord prolapse\n* Bishop score ≥6 on cervical assessment prior to labor induction\n* Reduced amniotic fluid volume (deepest vertical pocket \\\u003C30 mm)\n* Receiving epidural anesthesia prior to catheter insertion\n* Refusal to participate in the study and\u002For insufficient language skills to understand the study information and\u002For consent form",true,"FEMALE","18 Years","56 Years",{"count":138,"type":139},15,"ESTIMATED","INTERVENTIONAL",[69],"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.\n\nThe main questions it aims to answer are:\n\n* Is the INGA Sensor System safe to use during cervical ripening with the INGA balloon catheter?\n* How well does the sensor system measure uterine contractions and fetal heart rate during cervical ripening?\n* How does the use of the INGA balloon catheter affect cervical ripening and the time from induction to delivery?\n* How do participants and healthcare professionals evaluate the usability of the catheter and sensor system?\n\nAll participants in this study will receive the INGA balloon catheter with the attached sensor system. There is no comparison group.\n\nParticipants will:\n\n* Undergo routine assessments before labor induction, including medical history review, cervical examination, blood pressure and heart rate measurement, and fetal heart rate monitoring\n* Have the INGA balloon catheter placed in the cervix by a trained physician\n* Have a small sensor device attached to the external end of the catheter\n* Undergo standard fetal heart rate monitoring after placement\n* Keep the catheter and sensor in place until the catheter is expelled naturally or for up to 24 hours\n* Continue labor induction and delivery according to standard hospital practice\n* Complete a questionnaire about comfort and usability\n* Allow collection of information about labor, delivery, and newborn outcomes from medical records\n\nParticipation lasts from signing informed consent until hospital discharge.",[144,145,146,147],"Induced Labor","Cervical Ripening","Cervical Ripening and Induction of Labor","Balloon Catheter for Labor Induction",[149,150,151,152,153],"Cervical ripening","Induction of labor","Balloon catheter","Fetal monitoring","Uterine monitoring","NOT_YET_RECRUITING","2026-09-22",{"date":157,"type":158},"2026-09-29","ACTUAL",{"date":160,"type":139},"2026-09",{"date":162,"type":139},"2027-03-31",{"name":5,"class":6},1]