Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-05 @ 1:00 PM
Study NCT ID:
NCT01517633
Status:
UNKNOWN
Last Update Posted:
2012-01-25
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-24', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence / absence of stains comparing to a known color index printed on the product', 'timeFrame': '12 hours', 'description': 'Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.'}], 'secondaryOutcomes': [{'measure': 'Presence / absence of stains comparing to a known color index printed on the product', 'timeFrame': '12 hours', 'description': 'Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions.'}]}, 'conditionsModule': {'keywords': ['Amniotic fluid leakage', 'Urinary incontinence'], 'conditions': ['Amniotic Fluid Leakage']}, 'referencesModule': {'references': [{'pmid': '20569537', 'type': 'BACKGROUND', 'citation': 'El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.', 'detailedDescription': "Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women age 18 years and older attending delivery room.\n2. Stage of gestation: pregnancy between 16 and 42 weeks of gestation.\n3. Able and willing to read and sign an informed consent document.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if any of the following will be present:\n\n1. Prior use of any amniotic fluid detection test.\n2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.\n3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.\n4. Sexual intercourse within the past 24 hours.\n5. Confirmed diagnosis of any vaginal infection within the past 7 days.\n6. Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..\n7. Patients unable or unwilling to participate.\n8. Patients in active labor (or with regular contractions).'}, 'identificationModule': {'nctId': 'NCT01517633', 'briefTitle': 'Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine', 'orgStudyIdInfo': {'id': '300165-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A device for identifying between amniotic fluid and urine', 'interventionNames': ['Device: BirthSign']}], 'interventions': [{'name': 'BirthSign', 'type': 'DEVICE', 'description': 'When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.', 'armGroupLabels': ['A device for identifying between amniotic fluid and urine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}