Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT03789903
Status:
UNKNOWN
Last Update Posted:
2018-12-31
First Post:
2018-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2018-12-26', 'studyFirstSubmitQcDate': '2018-12-27', 'lastUpdatePostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'latency period', 'timeFrame': 'upto 48 hours', 'description': 'duration from ROM till the occurrence of active labor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rupture of Membranes; Premature']}, 'descriptionModule': {'briefSummary': 'AF lactate level could help in predicting the duration from ROM till delivery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. women with PPROM\n2. GA between 24 to 34 weeks\n\nExclusion Criteria:\n\n1. chorioamnionitis\n2. previous Preterm labor\n3. abruptio placentae\n4. UTI ,pyelonephritis'}, 'identificationModule': {'nctId': 'NCT03789903', 'briefTitle': 'Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes', 'orgStudyIdInfo': {'id': 'ain shams maternity hos'}}, 'armsInterventionsModule': {'interventions': [{'name': 'amniotic fluid lactate', 'type': 'DIAGNOSTIC_TEST', 'description': 'AF lactate'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Abbassya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed K Maklad, MD', 'role': 'CONTACT'}], 'facility': 'AinShams university maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Radwa R Ali, MD', 'role': 'CONTACT', 'email': 'radwaebed@yahoo.com', 'phone': '01283492979', 'phoneExt': '02002'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Radwa Rasheedy Ali', 'investigatorAffiliation': 'Ain Shams University'}}}}