[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-ripening-and-induction-of-labor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-ripening-and-induction-of-labor":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,75,96],{"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","2026-07-21",{"date":40,"type":41},"2026-07-22","ACTUAL",{"date":43,"type":22},"2026-08-01",{"date":45,"type":22},"2027-05-01",{"name":47,"class":48},"Aalto University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100624833","safety-and-usability-of-the-inga-catheter-for-labor-induction-inga-mdp-100624833","NCT07414771","Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)","A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction","INGA-MDP","Inclusion Criteria:\n\n* Pregnant women aged ≥18 and ≤56 years\n* An unripe cervix, ≤6 points according to the Bishop assessment (0-10 point scale)\n* Planned induction of labor by mechanical balloon catheter method\n* Examples of diagnoses as the basis for labor induction:\n\n  * Post-term pregnancy (≥41 weeks of gestation)\n  * Maternal request for labor induction\n  * Gestational diabetes\n  * Preeclampsia (with blood pressure \\\u003C150\u002F100)\n  * Well-controlled hypertension\n  * Cholestasis of pregnancy\n  * Humanitarian or psychosocial reasons\n* Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)\n* Singleton pregnancy\n* Cephalic presentation\n* The subject understands the study information and signs the consent form\n\nExclusion Criteria:\n\n* Preterm induction of labor (\\\u003C37 weeks of gestation)\n* Pathological CTG at inclusion\n* Spontaneous rupture of membranes at inclusion\n* Clinically significant vaginal bleeding with need of hospitalization in the third trimester\n* Clinically active vaginal or uterine infection\n* Maternal HIV, hepatitis C, or hepatitis B\n* Uterine scar (including previous cesarean section)\n* Condition of the fetus or mother requiring immediate delivery\n* Presence of eclampsia\n* Severe Pre-eclampsia (Blood pressure ≥160\u002F110 and any of the following: low platelet count (\\\u003C100 × 10 9\u002FL), HELLP, progressive renal insufficiency, pulmonary edema)\n* Severe fetal growth restriction (FGR, fetal growth \\\u003C -2 SD)\n* Estimated fetal weight ≥ 2SD or ≥ 95th percentile\n* Breech or transverse fetal position\n* Multiple pregnancy\n* Vasa previa or placenta previa\n* Umbilical cord prolapse\n* Maternal refusal to participate in the study and\u002For insufficient language skills to understand the study information and\u002For consent form",{"count":58,"type":22},45,[25],"The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term.\n\nThe study aims to assess the safety, usability, and performance of the INGA catheter when used for cervical ripening before labor. Researchers will also collect feedback from healthcare professionals and participants about the use of the device.\n\nParticipants are pregnant women at term with a single baby in a head-down position who meet the study eligibility criteria.\n\nParticipants will:\n\n* have the INGA balloon catheter inserted as part of labor induction,\n* receive standard clinical care according to hospital practice,\n* provide information about their experience and outcomes related to the device.\n\nThe results of this study will help determine whether the INGA catheter is safe and suitable for use in cervical ripening during labor induction.",[62,29,30],"Induction of Labor",[64,65,66],"Cervical ripening","Balloon catheter","Induction of labor","RECRUITING",{"date":40,"type":41},{"date":70,"type":41},"2026-07-01",{"date":72,"type":22},"2027-03-31",{"name":47,"class":48},3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100609466","open-randomized-feasibility-trial-on-the-safety-and-performance-of-the-inga-catheter-for-labor-induction-100609466","NCT07214948","Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction","An Open, Parallel-group, Randomized, Early Feasibility Trial to Evaluate the Initial Safety and Performance of the INGA Catheter in Labor Induction","INGA-RCT","Inclusion Criteria:\n\n* Pregnant women aged ≥18 and ≤56 years\n* An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale)\n* Planned induction of labor by balloon catheter method\n* Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)\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* Abnormal Cardiotocography (CTG) at inclusion\n* Spontaneous rupture of membranes at inclusion\n* Clinically significant vaginal bleeding with a need of hospitalization in the third trimester\n* Clinical active vaginal or uterine infection\n* Maternal Human Immunodeficiency Virus (HIV), hepatitis C, or hepatitis B\n* Uterine scar (including previous cesarean section)\n* Condition requiring immediate delivery of the fetus or mother\n* Presence of eclampsia\n* Severe Preeclampsia \\[Blood pressure (BP)≥ 160\u002F110 and any of the following: thrombocytopenia with platelet count \\\u003C100 × 10e9\u002FL, HELLP- syndrome ( Hemolysis, Elevated Liver enzymes and Low Platelets), progressive renal insufficiency, pulmonary edema \\]\n* Severe fetal growth restriction (Fetal Growth Restriction (FGR) fetal growth \\\u003C-2 SD\u002F\\\u003C10th percentile)\n* Estimated fetal weight ≥ 2 Standard Deviation \u002F≥ 95th percentile\n* Reduced amniotic fluid volume (deepest vertical pocket \\\u003C30 mill meter)\n* Breech or transverse fetal position\n* Multiple pregnancy\n* Vasa previa or placenta previa\n* Umbilical cord prolapses\n* Bishop score ≥6 on cervical assessment prior to labor induction\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",{"count":84,"type":22},40,[25],"This study investigates the safety and usability of the new INGA catheter for labor induction.\n\nLabor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.",[28,29,30],[66,34,64],{"date":40,"type":41},{"date":91,"type":41},"2026-07-03",{"date":93,"type":22},"2026-10-30",{"name":47,"class":48},2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100646556","cervical-ripening-balloon-3-hours-vs-12-hours-placement-100646556","NCT07689357","Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement","Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail","Inclusion Criteria:\n\n* Nulliparous or multiparous pregnant women.\n* Gestational age between 37 0\u002F7 and 41 6\u002F7 weeks of gestation.\n* Maternal age between 18 and 45 years.\n* Participant has provided signed informed consent.\n\nExclusion Criteria:\n\n* Presence of any contraindications for vaginal delivery.\n* Multifetal gestation.\n* Rupture of membranes prior to balloon insertion.\n* Favorable cervix, defined as a Bishop score greater than 6.\n* Cervical dilation greater than 2 cm.\n* Previous cesarean delivery or any other prior major uterine surgery.","45 Years",{"count":105,"type":22},164,[25],"The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.\n\nThe main questions it aims to answer are:\n\nDoes placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?\n\nDoes a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?\n\nResearchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.\n\nParticipants will:\n\nSign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).\n\nUndergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.\n\nHave the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.\n\nProceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.\n\nComplete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.",[109,30],"Labor Induction","2026-07-07",{"date":112,"type":41},"2026-07-08",{"date":114,"type":41},"2026-05-27",{"date":116,"type":22},"2028-11-01",{"name":118,"class":48},"Rambam Health Care Campus",1]