Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-29 @ 7:05 AM
Study NCT ID:
NCT05517512
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2022-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between Protein 13 and Gestational Hypertensive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum biomarkers and GHD', 'timeFrame': '9 months', 'description': 'The primary outcome is the ability of early ELISA estimation of biomarkers for prediction of GHD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Hypertension']}, 'descriptionModule': {'briefSummary': 'the attendants of the clinic with a one-missed period (T0) underwent determination of baseline blood pressure (BP) measures and gave blood samples for estimation of levels of placental growth factor (PLGF), soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy protein 13 (PP13). The same evaluation was repeated on the 6th, 24th, 32nd, and 36th gestational week (GW). Twenty non-pregnant women gave samples as a negative control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '33 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Non Hypertensive pregnant women', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normotensive women who attended the clinic with a one-missed period (T0)\n\nExclusion Criteria:\n\n* History of essential hypertension (HTN)\n* renal diseases\n* hepatic diseases\n* cardiac diseases\n* metabolic syndrome\n* body mass index (BMI) \\>35 kg/ m2\n* congenital heart diseases'}, 'identificationModule': {'nctId': 'NCT05517512', 'briefTitle': 'Relation Between Protein 13 and Gestational Hypertensive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Low Serum Pregnancy Protein 13 Early in Pregnancy Might Predict the Oncoming Gestational Hypertensive Disorders, Especially Early-onset Preeclampsia', 'orgStudyIdInfo': {'id': 'Rc5.6.2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gestational Hypertension', 'interventionNames': ['Diagnostic Test: Estimation of Protein 13']}, {'label': 'Pre Eclampsia', 'interventionNames': ['Diagnostic Test: Estimation of Protein 13']}, {'label': 'Control', 'interventionNames': ['Diagnostic Test: Estimation of Protein 13']}], 'interventions': [{'name': 'Estimation of Protein 13', 'type': 'DIAGNOSTIC_TEST', 'description': "Serum biomarkers' levels were measured using enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions and were read using a 96 well microplate ELISA reader (Dynatech. MR 7000)\n\n1. Human placental growth factor (PLGF) was measured with the enzyme-linked immunoassay (ELISA) kit (catalog no. DPG00 SPG00 PDPG00, R\\&D Systems Inc., Minneapolis, USA) by quantitative sandwich enzyme immunoassay technique (20).\n2. Human soluble fms-like tyrosine kinase-1 (sFlt-1) was measured with the enzyme-linked immunoassay (ELISA) kit (catalog no. MBS601616, MyBioSource, Inc., California, San Diego, USA) by quantitative sandwich enzyme immunoassay technique (21).\n3. Human pregnancy protein 13 was measured with the enzyme-linked immunoassay (ELISA) kit (catalog no. ab100553, Abcam Inc., Cambridge, USA) by quantitative sandwich enzyme immunoassay technique (22).", 'armGroupLabels': ['Control', 'Gestational Hypertension', 'Pre Eclampsia']}]}, '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': 'Assistant professor of gynecology', 'investigatorFullName': 'Amr Sharaf Eldein', 'investigatorAffiliation': 'Benha University'}}}}