[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"balloon-catheter-for-labor-induction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:balloon-catheter-for-labor-induction":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100626180","evaluation-of-the-inga-sensor-system-for-fetal-and-uterine-monitoring-during-cervical-ripening-100626180",false,"NCT07432282","Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening","Early Feasibility Study on the Safety and Performance of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening With the INGA Balloon Catheter","INGA-SEN","Inclusion Criteria:\n\nPregnant 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\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 requiring immediate delivery of the fetus or mother\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","FEMALE","18 Years","56 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31],"Induction of Birth","Cervical Ripening","Cervical Ripening and Induction of Labor","Balloon Catheter for Labor Induction",[33,34,29,35,36],"Induction of labour","Balloon Catheter","Uterine monitoring","Fetal monitoring","NOT_YET_RECRUITING","2026-02-19",{"date":40,"type":41},"2026-02-25","ACTUAL",{"date":43,"type":22},"2026-05-01",{"date":45,"type":22},"2027-05-01",{"name":47,"class":48},"Aalto University","OTHER"]