Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-15 @ 1:18 AM
Study NCT ID:
NCT06214702
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serpin C and Soluble Fms-like Tyrosine Kinase-1 Levels in Normotensive Pregnant Women May Predict the Development of Preeclampsia
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Role of Biomarkers in detection of GHTN', 'timeFrame': '9 months', 'description': "The predictability of serum biomarkers' levels estimated at enrolment for the development of GHTN."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': 'Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were having monthly follow-up of pregnancy and determination of BP measures, and estimation of the serum levels of the studied biomarkers.\n\nPatients who developed GHTN at the 20th GW were grouped as GHTN group and those who were normotensive at the 20th GW were considered as control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normotensive pregnant women had singleton fetus presenting during the 1st trimester\n* free of exclusion criteria\n\nExclusion Criteria:\n\n* Age\n* Sex\n* Hypertension'}, 'identificationModule': {'nctId': 'NCT06214702', 'briefTitle': 'Serpin C and Soluble Fms-like Tyrosine Kinase-1 Levels in Normotensive Pregnant Women May Predict the Development of Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Deregulated Serum Levels of Serpin C and Soluble Fms-like Tyrosine Kinase-1 Might Predict the Development of Preeclampsia in Normotensive Pregnant Women', 'orgStudyIdInfo': {'id': 'RC 7.1.2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with diastolic blood pressure (DBP) after the 20th GW up ≥140 or 90 mmHg without proteinuria.', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Control Group', 'description': 'Patients were normotensive at the 20th GW.', 'interventionNames': ['Diagnostic Test: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'description': 'ELISA estimation of PLGF, sFlt-1 and Serpin C', 'armGroupLabels': ['Control Group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'El- Qalyobia', 'country': 'Egypt', 'facility': 'Banha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics and gynecology', 'investigatorFullName': 'Omar K. Naser', 'investigatorAffiliation': 'Benha University'}}}}