Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-20 @ 6:03 AM
Study NCT ID:
NCT02982356
Status:
UNKNOWN
Last Update Posted:
2016-12-05
First Post:
2016-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002869', 'term': 'Chromosome Aberrations'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011189', 'term': 'Potassium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017680', 'term': 'Potassium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate for the operation', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'long-term complications after surgery', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chromosome Abnormality', 'Twin Pregnancy With Antenatal Problem']}, 'descriptionModule': {'briefSummary': 'The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies:\n\n1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy.\n2. fetal chromosomal abnormalities'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ultrasound diagnosis as twin pregnancy\n* at 11-14 gestational weeks\n\nExclusion Criteria:\n\n* Multiple pregnancies (three or more)\n* Maternal history of chromosome aneuploidy abnormality or tumor'}, 'identificationModule': {'nctId': 'NCT02982356', 'briefTitle': 'Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy', 'orgStudyIdInfo': {'id': 'ShanghaiFMIH-FMU2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fetal Selective Reduction Technology', 'description': 'Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure', 'interventionNames': ['Procedure: Fetal Selective Reduction Technology', 'Drug: Potassium Chloride']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'normal dichorial twins without any intervention'}], 'interventions': [{'name': 'Fetal Selective Reduction Technology', 'type': 'PROCEDURE', 'description': 'Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16\\~24 weeks, 24\\~27+6 weeks,\\>28weeks', 'armGroupLabels': ['Fetal Selective Reduction Technology']}, {'name': 'Potassium Chloride', 'type': 'DRUG', 'armGroupLabels': ['Fetal Selective Reduction Technology']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The Individual Participant Data sharing plan will be discussed with the other collaborators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, {'name': 'International Peace Maternity and Child Health Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}