[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624833":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":82,"collaborators":84,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":20,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":116,"whyStopped":20,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Aalto University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"INGA catheter for cervical ripening","EXPERIMENTAL","Participants in this arm will undergo cervical ripening using the INGA cervical ripening balloon catheter as part of labor induction. The catheter is inserted into the cervix and filled with saline according to the device instructions. The balloon may remain in place for up to 24 hours unless expelled spontaneously earlier. Cervical status is assessed before and after catheter use using the Bishop score. Participants will receive standard obstetric care throughout labor induction and labor. Data on device usability, insertion experience, pain, retention time, and delivery outcomes will be collected. Participants and healthcare professionals involved in the procedure will also provide feedback on catheter performance and usability.",[13],"Device: Cervical ripening, labor induction",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Cervical ripening, labor induction","This study uses the INGA cervical ripening balloon catheter for labor induction, with standardized insertion and saline filling according to device instructions, allowing the balloon to remain in place up to 24 hours. The trial systematically collects data on catheter usability, insertion experience, patient pain, retention time, and delivery outcomes, as well as feedback from both participants and healthcare professionals regarding device performance and usability. Cervical status is evaluated using the Bishop score before and after catheter use.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Leena Rahkonen, MD, PhD, Assoc.prof","Aalto University, INGA Health","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Kirsi Roivainen, Master of Health","CONTACT","+358 (0)50 534 7653","kirsi.roivainen@mdsfinland.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Heidi Kruit, MD, PhD, Assoc.prof","+358 (0)50 428 4685","heidi.kruit@hus.fi",[37,54,68],{"facility":38,"status":20,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Helsinki University Hospital","Helsinki","HUS","00029","Finland","FI",{"type":45,"coordinates":46},"Point",[47,48],24.93545,60.16952,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":53,"phoneExt":20,"email":35},"Heidi Kruit, MD, PhD, Associate Professor","+358504284685",{"facility":55,"status":20,"city":56,"state":20,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Hospital Nova","Jyväskylä","40620",{"type":45,"coordinates":59},[60,61],25.72088,62.24147,{"lat":61,"lon":60},[64],{"name":65,"role":29,"phone":66,"phoneExt":20,"email":67},"Kirsi Väyrynen, MD, PhD","+35814 269 1811","kirsi.vayrynen@hyvaks.fi",{"facility":69,"status":20,"city":70,"state":20,"zip":71,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Tampere University Hospital","Tampere","33101",{"type":45,"coordinates":73},[74,75],23.78712,61.49911,{"lat":75,"lon":74},[78],{"name":79,"role":29,"phone":80,"phoneExt":20,"email":81},"Kati Tihtonen, MD, PhD, Associate professor","+358207 907 330","kati.tihtonen@pirha.fi",{"type":83,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[85,86,88],{"name":69,"class":6},{"name":87,"class":6},"Jyväskylä Central Hospital",{"name":89,"class":6},"Helsinki University Central Hospital","100624833","safety-and-usability-of-the-inga-catheter-for-labor-induction-inga-mdp-100624833",false,"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","FEMALE","18 Years","56 Years",{"count":102,"type":103},45,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.",[109,110,111],"Induction of Labor","Cervical Ripening","Cervical Ripening and Induction of Labor",[113,114,115],"Cervical ripening","Balloon catheter","Induction of labor","NOT_YET_RECRUITING","2026-05-22",{"date":119,"type":120},"2026-05-26","ACTUAL",{"date":122,"type":103},"2026-05",{"date":124,"type":103},"2027-03-31",{"name":5,"class":6},3]