Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-04-13 @ 7:43 PM
Study NCT ID:
NCT01735695
Status:
UNKNOWN
Last Update Posted:
2013-04-30
First Post:
2012-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Evaluation Study for a New Meconium Detection Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-28', 'studyFirstSubmitDate': '2012-11-25', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meconium concentration in amniotic fluid', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meconium', 'concentration', 'level'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.', 'detailedDescription': 'Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally.\n\nMeconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written or oral informed consent to participate in the study and agree to comply with study procedures.\n* Pregnant.\n* Intend to seek medical care during pregnancy.\n\nExclusion Criteria:\n\n* Amniotic fluid samples are mixed with urine.'}, 'identificationModule': {'nctId': 'NCT01735695', 'briefTitle': 'Performance Evaluation Study for a New Meconium Detection Test', 'organization': {'class': 'OTHER', 'fullName': 'Laniado Hospital'}, 'officialTitle': 'Performance Evaluation Study for a New Meconium Detection Test', 'orgStudyIdInfo': {'id': 'Laniado25112012'}, 'secondaryIdInfos': [{'id': 'Laniado25122012-1', 'type': 'OTHER', 'domain': 'Laniado Hospital'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Birgita Weintrov, MD', 'role': 'CONTACT'}, {'name': 'Brigita Weintrov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laniado Hospital', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Brigita Weitrov, MD', 'role': 'CONTACT', 'email': 'morami12@gmail.com', 'phone': '972-50-8840757'}], 'overallOfficials': [{'name': 'Brigita Wintrov, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laniado Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laniado Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}