Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-27 @ 7:33 AM
Study NCT ID:
NCT02506894
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in fetal middle cerebral artery Doppler indices', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'maternal adverse effects of magnesium sulfate', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Two groups of women with preterm labor will be included. One will receive magnesium sulfate for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.', 'detailedDescription': 'The study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices \\[Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)\\] will be recorded before and after treatment in both groups. Results of Doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with preterm labor\n* gestational age less than 32 weeks\n* singleton pregnancy\n\nExclusion Criteria:\n\n* contraindication or hypersensitivity to magnesium\n* preeclampsia\n* multiple pregnancy\n* intake of magnesium sulfate in this pregnancy before'}, 'identificationModule': {'nctId': 'NCT02506894', 'briefTitle': 'Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection', 'orgStudyIdInfo': {'id': 'Mgso4 for neuroprotection'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'magnesium sulfate', 'description': 'this group will receive magnesium sulfate loading dose 6 g in 500 cc of ringer solution over 20 minutes then maintenance dose of 1 g/ hour for 24 hours.', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'this group will receive sodium chloride 0.9% solution for 24 hours.', 'interventionNames': ['Other: 0.9% sodium chloride solution']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'otherNames': ['MgSO4'], 'description': 'magnesium sulfate will be given for 24 hours', 'armGroupLabels': ['magnesium sulfate']}, {'name': '0.9% sodium chloride solution', 'type': 'OTHER', 'description': 'normal saline will be given as intravenous drip over 24 hours', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ghada Abdel Fattah Abdel Moety, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of Obstetrics and Gynecology', 'investigatorFullName': 'Ghada Abdel Fattah', 'investigatorAffiliation': 'Cairo University'}}}}