Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 5:27 PM
Study NCT ID:
NCT04921150
Status:
UNKNOWN
Last Update Posted:
2021-06-10
First Post:
2021-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standardized Management of Complex Twins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized management system of twin pregnancy clinic', 'timeFrame': '1 year', 'description': 'S/D score and Apgar score of complex twin pregnancy assessed by clinical doctors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Twins']}, 'descriptionModule': {'briefSummary': 'At present, the incidence of monochorionic twins in all pregnancies is around 3-5‰ worldwide.In 2019, the twin Committee of China Maternal and Child Health Association conducted statistics from 48 medical units all over the country, showing that there were 4,876 cases of monochorionic twins, accounting for 10.2‰ of all pregnancies.In addition to increased incidence of preterm delivery, miscarriage, and maternal complication, the unique placental vascular structure of monochorionic twins is associated with complex fetal complication such as twin-twin transfusion syndrome, selective intraurine growth restriction, twin anaemia-erythrocytosis sequence, twin reversed arterial perfusion sequence, one of twin with dysplasia, twins with single amniotic sac and conjunctions are common. At present, there is no unified standard for the diagnosis and treatment of these complicated twins, and various treatment methods have a great impact on the pregnancy outcome and fetal prognosis.Therefore, the standardized management of complex twins benefits diagnosis and treatment of complex twins and improves fetal prognosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ncomplex twin disease 18-45 years\n\nExclusion Criteria:\n\nsingle pregnancy normal twin pregnancy'}, 'identificationModule': {'nctId': 'NCT04921150', 'briefTitle': 'Standardized Management of Complex Twins', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Standardized Management of Complex Twins', 'orgStudyIdInfo': {'id': 'SMOCT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'standardization management', 'type': 'OTHER', 'description': 'Apply standardization management to improve the outcomes of pregnancy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caixia Liu, master', 'role': 'CONTACT', 'email': 'liucx1716@163.com', 'phone': '18804083801'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caixia Liu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shengjing Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Caixia Liu', 'investigatorAffiliation': 'Shengjing Hospital'}}}}