Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-06 @ 9:55 AM
Study NCT ID:
NCT01846156
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Magnesium Sulphate Protocol for Pre-eclampsia
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of MgSo4 treatment', 'timeFrame': '1 year', 'description': 'treatment duration'}], 'secondaryOutcomes': [{'measure': 'ICU admission', 'timeFrame': '1 year', 'description': 'ICU admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['convulsion rate'], 'conditions': ['Pre-eclampsia']}, 'referencesModule': {'references': [{'pmid': '37815037', 'type': 'DERIVED', 'citation': 'Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.'}]}, 'descriptionModule': {'briefSummary': 'there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol', 'detailedDescription': 'The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.\n\nThe study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-\n\n* Systolic blood pressure ≥ 160.\n* Diastolic blood pressure ≥ 110.\n* Proteinuria \\> +2 by dip stick.\n* Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).\n* Fetal growth restriction (IUGR).\n\nAfter obtaining an informed consent the patients will be subjected to the following:\n\n* Careful history taking including age, parity, gestational age.\n* Complete physical examination and assessment of the blood pressure.\n* Urine analysis by dipstick.\n* All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .\n\nUsing Random Number Table, the sample size will be divided into three categories:-\n\n* Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.\n* Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.\n* Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.\n\nInclusion criteria:\n\n* Pregnant females ≥20 weeks of gestation.\n* Pregnant females with criteria of severe pre-eclampsia.\n* Single or multi-fetal pregnancy.\n* Primigravida or Multigravida.\n\nExclusion criteria:\n\n* Pregnant females \\< 20 weeks gestation.\n* Pregnant females with history of epilepsy.\n* Pregnant females with diabetes.\n* Pregnant females with chronic hypertension.\n* Pregnant females with renal disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females ≥20 weeks of gestation.\n* Pregnant females with criteria of severe pre-eclampsia.\n* Single or multi-fetal pregnancy.\n* Primigravida or Multigravida.\n\nExclusion Criteria:\n\n* Pregnant females \\< 20 weeks gestation.\n* Pregnant females with history of epilepsy.\n* Pregnant females with diabetes.\n* Pregnant females with chronic hypertension.\n* Pregnant females with renal disease.'}, 'identificationModule': {'nctId': 'NCT01846156', 'briefTitle': 'New Magnesium Sulphate Protocol for Pre-eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '52103'}, 'secondaryIdInfos': [{'id': '52013', 'type': 'REGISTRY', 'domain': 'Kasr Aliny'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abrreviated MgSO4 protocol', 'description': '\\- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.', 'interventionNames': ['Drug: MgSO4']}, {'type': 'EXPERIMENTAL', 'label': 'No maintenance protocol', 'description': '\\- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate', 'interventionNames': ['Drug: MgSO4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard MgSO4 protocol', 'description': '\\- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.', 'interventionNames': ['Drug: MgSO4']}], 'interventions': [{'name': 'MgSO4', 'type': 'DRUG', 'description': 'A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \\& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University', 'armGroupLabels': ['Abrreviated MgSO4 protocol', 'No maintenance protocol', 'standard MgSO4 protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Kasr Alainy hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Waleed El-khayat, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetrics & Gynecology', 'investigatorFullName': 'Waleed El-khayat', 'investigatorAffiliation': 'Cairo University'}}}}