Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT03205020
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2017-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of Amyloid A level in women with preterm labour', 'timeFrame': '6 months', 'description': 'venous sample will be taken from each participant from onset of labour, Amyloid a level will be calculated'}], 'secondaryOutcomes': [{'measure': 'neonatal complications', 'timeFrame': '6 months', 'description': 'preterm baby will be examined at neonatal intensive care unit by neonatologist.\n\n• Admission to Neonates intensive care unit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Labor']}, 'referencesModule': {'availIpds': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/25118503', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '58 pregnant women will be recruited', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women, age 18 - 35.\n* Gestational age: 28 - 36+6 weeks.\n* Singleton pregnancy.\n* No past history of any medical disorder and with no other medical complications during pregnancy\n* Nonsmoker.\n* Diagnosis of preterm labor is based on the American College of Obstetricians and Gynecologists Guidelines\n\nCriteria of preterm delivery:\n\n1. Gestational age: 28 - 36+6 weeks\n2. Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes)\n3. cervical dilation ≥ 4 cm\n4. Cervical effacement ≥ 80%.\n\nExclusion Criteria:\n\n* Of any patient with the following risk factors for preterm labor:\n\n * Over distended uterus .\n * hemorrhage\n * Uterine anomalies'}, 'identificationModule': {'nctId': 'NCT03205020', 'briefTitle': 'Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.', 'orgStudyIdInfo': {'id': 'amyloid a'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women with preterm labor', 'interventionNames': ['Diagnostic Test: serum amyloid a test']}, {'label': 'women delivered at full term', 'interventionNames': ['Diagnostic Test: serum amyloid a test']}], 'interventions': [{'name': 'serum amyloid a test', 'type': 'DIAGNOSTIC_TEST', 'description': '* Women who are diagnosed with preterm labor (28-36 weeks) will be enrolled in this study. Serum samples will be collected from all women before any intervention. All women will be sampled once at the time of admission.\n* Venous blood sample (5 c.c) will be taken from each participant for examination of serum amyloid A.\n* The collected blood will be centrifuging and serum will be stored to measure the level of amyloid A by (ELISA) technique in clinical pathology department- Ain shams University', 'armGroupLabels': ['women delivered at full term', 'women with preterm labor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed hussien, MD', 'role': 'CONTACT', 'phone': '01061460044'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'mona cairo nematallah, MS', 'role': 'CONTACT', 'email': 'drmonanematallah11@gmail.com', 'phone': '01061490044', 'phoneExt': 'ain shams'}, {'name': 'MONA M, MS', 'role': 'CONTACT', 'email': 'newnononew@gmail.com', 'phone': '01272207585'}], 'overallOfficials': [{'name': 'mona mohamed, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mona nematallah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'mona nematallah', 'investigatorAffiliation': 'Ain Shams University'}}}}