Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-03-13 @ 3:07 AM
Study NCT ID:
NCT03047304
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2017-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Effect on Embryonal PR Interval
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-02-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2017-02-06', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged PR interval', 'timeFrame': '20 min after magnesium treatment', 'description': 'PR will be measured by Mitral-aorta doppler'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Labor']}, 'referencesModule': {'references': [{'pmid': '3552543', 'type': 'BACKGROUND', 'citation': 'Gums JG. Clinical significance of magnesium: a review. Drug Intell Clin Pharm. 1987 Mar;21(3):240-6. doi: 10.1177/106002808702100301.'}, {'pmid': '1710436', 'type': 'BACKGROUND', 'citation': 'Agus ZS, Morad M. Modulation of cardiac ion channels by magnesium. Annu Rev Physiol. 1991;53:299-307. doi: 10.1146/annurev.ph.53.030191.001503. No abstract available.'}, {'pmid': '10994748', 'type': 'BACKGROUND', 'citation': 'Laurant P, Touyz RM. Physiological and pathophysiological role of magnesium in the cardiovascular system: implications in hypertension. J Hypertens. 2000 Sep;18(9):1177-91. doi: 10.1097/00004872-200018090-00003.'}, {'pmid': '10913494', 'type': 'BACKGROUND', 'citation': 'Glickstein JS, Buyon J, Friedman D. Pulsed Doppler echocardiographic assessment of the fetal PR interval. Am J Cardiol. 2000 Jul 15;86(2):236-9. doi: 10.1016/s0002-9149(00)00867-5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of gestation. High concentration of Magnesium in the blood stream known as cause of conduction abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our work is to evaluate the PR intervals in embryos after maternal treatment with magnesium during preterm labor.', 'detailedDescription': 'We will recruit 25 woman with threaten preterm labor, magnesium blood level and PR interval will be evaluated before magnesium loading dose (4gr) and 20 minutes after the loading dose.\n\nPR interval will be evaluated by Mitral-Aorta Doppler.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women at risk for preterm labor before 32 week of gestation\n\nExclusion Criteria:\n\n* Fetal malformations\n* Maternal Lupus\n* Fetal conduction abnormalities'}, 'identificationModule': {'nctId': 'NCT03047304', 'briefTitle': 'Magnesium Effect on Embryonal PR Interval', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Magnesium Effect on Embryonal PR Interval', 'orgStudyIdInfo': {'id': '0531-15-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Women in risk for preterm labor', 'description': 'Women in risk for preterm labor treated with magnesium.', 'interventionNames': ['Diagnostic Test: Trans abdominal sonography']}], 'interventions': [{'name': 'Trans abdominal sonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Trans abdominal sonography in order to measure fetal PR interval.', 'armGroupLabels': ['Women in risk for preterm labor']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ola Gutzeit, MD', 'role': 'CONTACT', 'email': 'ola.gutzeit@gmail.com', 'phone': '972543088220'}], 'overallOfficials': [{'name': 'Ola Gutzeit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ola Gutzeit MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}