Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-01 @ 7:20 AM
Study NCT ID:
NCT05246761
Status:
UNKNOWN
Last Update Posted:
2022-04-22
First Post:
2022-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 924}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-17', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vignial birth rate', 'timeFrame': 'up to 84 hours', 'description': 'After the treatment of balloon catheter for 12 hours +oxytocin induction for up tp 72 hours, the mode of delivery will be konwn and recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trial of Labor After Cesarean', 'Vaginal Birth After Cesarean', 'Bishop Score', 'Failed Mechanical Induction', 'Balloon Catheter for Labor Induction', 'Unfavorable Cervix']}, 'referencesModule': {'references': [{'pmid': '30723900', 'type': 'BACKGROUND', 'citation': 'Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunne F, Duvekot JJ, van Eyck J, Gaugler-Senden I, de Groot CJM, Franssen MTM, van Gemund N, Langenveld J, de Leeuw JW, Oude Lohuis EJ, Oudijk MA, Papatsonis D, van Pampus M, Porath M, Rombout-de Weerd S, van Roosmalen JJ, van der Salm PCM, Scheepers HCJ, Sikkema MJ, Sporken J, Stigter RH, van Wijngaarden WJ, Woiski M, Mol BWJ, Bloemenkamp KWM; PROBAAT-S project group. Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix. Acta Obstet Gynecol Scand. 2019 Jul;98(7):920-928. doi: 10.1111/aogs.13558. Epub 2019 Mar 7.'}, {'pmid': '29490397', 'type': 'BACKGROUND', 'citation': 'Battarbee AN, Palatnik A, Peress DA, Grobman WA. The Association between Cervical Exam after Ripening with Foley Balloon Catheter and Outcomes of Nulliparous Labor Induction. Am J Perinatol. 2018 Aug;35(10):1001-1005. doi: 10.1055/s-0038-1635091. Epub 2018 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, prospective, observational clinical trial study. 924 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the prior cesarean section group, pregnant women with one previous cesarean section who are willing to try to the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the control group, pregnant women after 39 weeks of gestation without vaginal labor contraindications will be enrolled. Whether in the experimental group or the control group, their cervical bishop score was less than 6 points, and they all will be induced by balloon catheter + oxytocin. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In the cesarean section group, the extra inclusion criteria includes:\n\nOnly one prior low transverse uterine incision;\n\nExtra exclusion criteria:\n\n1. With mutiple history of c esction;\n2. Prior extensive transfundal uterine surgery, such as for fetal surgery, myomectomy, or uterine reconstruction; Prior classical vertical uterine incision, or an inverted "T" or "J" incision;\n3. Short interpregnancy interval;\n4. Prior uterine rupture or dehiscence, or cesarean scar pregnancy;\n5. Evaluated fetal birth weight\\> 4000 g. In the non-cesarean section group, the extra criteria should include: nulliparous', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Volunteers sign the informed consent;\n2. Age: 20-40 years;\n3. Singleton, a cephalic presentation;\n4. No contradiction to vaginal delivery; 5.39\\~42 weeks.\n\nExclusion criteria:\n\n1. Konwn contraindication to vaginal delivery or severe complications;\n2. Multiple gestation;\n3. Uterine malformation;\n4. Severe psychiatric disorder;\n5. Without family's support."}, 'identificationModule': {'nctId': 'NCT05246761', 'briefTitle': 'Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'To Study the Effectiveness and Safety of Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section: Multicenter, Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'JPPTOLAC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cesarean section group', 'description': 'In the cesarean section group, all the pregnant women had only one prior cesarean section.', 'interventionNames': ['Device: Balloon catheter']}, {'label': 'Non-cesarean section group', 'description': 'In the non-cesarean section group, all the pregnant women are primiparaļ¼and never had a cesarean section.', 'interventionNames': ['Device: Balloon catheter']}], 'interventions': [{'name': 'Balloon catheter', 'type': 'DEVICE', 'description': 'In the two groups, if their bishop score \\<6, they will receive the cervical riening by the balloon catheter, and then the oxytocin if necessary.', 'armGroupLabels': ['Cesarean section group', 'Non-cesarean section group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tang Jinhai', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jiang Ziyan, Ph.D', 'role': 'CONTACT', 'email': 'zyjiangchm@163.com', 'phone': '13512534017'}], 'overallOfficials': [{'name': 'Jiang Ziyan, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}