Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-24 @ 10:22 PM
Study NCT ID:
NCT02031393
Status:
UNKNOWN
Last Update Posted:
2014-01-31
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing First Trimester Markers for the Identification of High Risk Twin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Maternal serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-30', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The development of preeclampsia', 'timeFrame': 'after delivery', 'description': 'the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension'}], 'secondaryOutcomes': [{'measure': 'intra uterine growth restriction', 'timeFrame': 'after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small for Gestational Age (Disorder)', 'Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women from 11 -14 weeks of gestation\n\nExclusion Criteria:\n\n* nuchal thickness above 3 mm,\n* Chronic hypertension,\n* thrombophilia,\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT02031393', 'briefTitle': 'Establishing First Trimester Markers for the Identification of High Risk Twin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester', 'orgStudyIdInfo': {'id': '217/13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'singelton pregnancy', 'description': 'will be followed 11-14 weeks and 19-28 weeks of gestation and after birth'}, {'label': 'twin pregnancy', 'description': 'will be followed 11-14 weeks and 19-28 weeks of gestation and after birth'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Be’er Ya‘aqov', 'state': 'Zrifin', 'country': 'Israel', 'facility': 'Assaf Harofe obstetric department', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}