Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-24 @ 11:27 PM
Study NCT ID:
NCT02677233
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Vitamin D Deficiency and Preeclampsia: A Case Control Study
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vitamin D level in preeclamptic and non preeclamptic women', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': 'To find out if lower levels of vitamin D is more prevalent in preeclamptic women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be carried out on 90 pregnant women recruited at pre labour room at Ain Shams University Maternity Hospital. They will be divided into preeclamptic group and non preeclamptic group, 45 cases in each one', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parity: primigravida.\n* Age: 18 - 35 years.\n* Singleton pregnancy.\n* Gestational age: 36-40 weeks.\n* No past history of any medical disorder and with no other medical complications during pregnancy\n\nExclusion Criteria:\n\n* Women with preexisting medical conditions like rheumatoid arthritis, thyroid, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption and lupus.\n* History of intake of medications influencing bone, vitamin D or calcium metabolism e.g. antiepileptic, theophylline, antitubercular drugs in the last 6 months.\n* Women with multiple pregnancy.\n* Women with congenital fetal malformation.\n* Women with known thrombophilia'}, 'identificationModule': {'nctId': 'NCT02677233', 'briefTitle': 'Association Between Vitamin D Deficiency and Preeclampsia: A Case Control Study', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'orgStudyIdInfo': {'id': 'vid-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preeclamptic group', 'description': '1. Blood pressure: greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic on two occasions at least 4 hours apart after 20 weeks of gestation (Roberts et al., 2013).\n2. Proteinuria: protein/creatinine ratio greater than or equal to 0.3\n3. In the absence of proteinuria, a new-onset hypertension with new onset of the following:\n\n * thrombocytopenia: platelet count less than 100.000/microliter\n * renal insufficiency: serum creatinine greater than 1.1 mg/dl\n * impaired liver function: elevated concentration of liver transaminases\n * pulmonary edema\n * cerebral or visual symptoms\n * Severe right upper quadrant or epigastric pain unresponsive to medication.'}, {'label': 'non preeclamptic group', 'description': 'All are normotensive with blood pressure \\<140/90 with no proteinuria.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'mohamed salah', 'investigatorFullName': 'Mohamed Salah sayed', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}