Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 2:27 PM
Study NCT ID:
NCT06791668
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], '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'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2025-01-19', 'studyFirstSubmitQcDate': '2025-01-19', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of eclamptic fits', 'timeFrame': 'within 24 hours before or after delivery', 'description': 'Development of generalized tonic clonic convulsions in pregnant women with preeclampsia'}], 'secondaryOutcomes': [{'measure': 'ICU admission', 'timeFrame': 'within 48 hours before or after delivery', 'description': 'admission to the intensive care unit'}, {'measure': 'magnesium sulphate toxicity', 'timeFrame': 'within 48 hours before or after delivery', 'description': 'clinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level \\>8.4mg/dl'}, {'measure': 'primary postpartum hemorrhage', 'timeFrame': 'within 24 hours after delivery', 'description': 'occurrence of complications as primary postpartum hemorrhage (the loss of 500 ml or more of blood from the genital tract within 24 hours of the birth of a baby)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eclampsia', 'magnesium sulphate', 'intensive care unit', 'pulmonary edema'], 'conditions': ['Preeclampsia (PE)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). The medication (magnesium sulphate) helps to prevent seizures. The main question this study aims to answer is:\n\nWhat are the different regimens of magnesium sulphate that are used to prevent seizures in pregnant women with severe pre-eclampsia?\n\nParticipants already have taken the magnesium sulphate as part of their regular medical care for severe pre-eclampsia. Researchers will look into the records of the participants in the past 5 years to collect the data.', 'detailedDescription': 'This will be a retrospective study describing the different regimens of MgSO4 used in patients diagnosed with SPE in Ain Shams University Maternity Hospital (ASUMH), and the occurrence of eclamptic fits and any other complications with each of them.\n\nMethodology:\n\n1. Protocol approval will be sought from ethical committee and hospital administration.\n2. Screening of all hospital records over the past 5 years to identify eligible records.\n3. Eligible records will be reviewed to extract the following data:\n\n Age, Parity, Gestational age, BMI, Prior medical disorders, previous surgeries - including cesarean section (CS).\n\n Data upon admission: (Blood pressure, albuminuria) Available labs (CBC, AST, ALT, serum creatinine, PTT, INR) Timing (since admission) and route of delivery. Regimen of MgSO4 used (loading and maintenance doses, the route, and total time of therapy - antepartum and postpartum); any changes in dosage, and the reason for change.\n\n Any DOCUMENTED patient-reported MgSO4 side effects (nausea, vomiting, muscle weakness, palpitations, hypotension dizziness).\n\n Any DOCUMENTED signs of magnesium toxicity (clinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level \\>8.4mg/dl) Occurrence of eclamptic fits despite MgSO4 therapy, and timing, duration, how it was managed.\n\n Maternal admission to intensive care unit (ICU). Other complications (pulmonary edema, postpartum hemorrhage) Neonatal ICU (NICU) admission.\n\n All files with SPE will be examined. The number of files excluded from analysis will be noted as well as a table for the different causes of exclusion .\n\n Files showing serum magnesium level will be also analyzed in more detailed tables together with the reasons behind checking the serum level.\n4. Data will be recorded in a case report form (appendix 1)\n5. Statistical analysis will be done accordingly.\n\nEthical Consideration:\n\n* The study design will be approved by the Local Ethics committee, Faculty of Medicine, Ain Shams University.\n* Confidentiality will be respected in all levels of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital records will be reviewed for pregnant women presented to Ain Shams University Maternity Hospital (ASUMH) diagnosed as a case of preeclampsia with criteria of severity:\n\nPreeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All hospital records of patients diagnosed as preeclampsia with severe features planned to receive magnesium sulphate.\n\nExclusion Criteria:\n\n* Records with missing data about the regimen of magnesium sulphate used'}, 'identificationModule': {'nctId': 'NCT06791668', 'briefTitle': 'Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Comparison of Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)', 'orgStudyIdInfo': {'id': 'FMASU MS 619/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant women with severe preeclampsia', 'description': 'Preeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherif Ashoush, MD', 'role': 'CONTACT', 'email': 'sherifashoush@med.asu.edu.eg', 'phone': '20201222660266'}, {'name': 'Ahmed Sakr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Rania HM Ahmed, MD', 'role': 'CONTACT', 'email': 'raneyah@med.asu.edu.eg', 'phone': '20201200522444'}, {'name': 'Sherif Ashoush, MD', 'role': 'CONTACT', 'email': 'sherifashoush@med.asu.edu.eg'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'start date: after publication of the study results end date: for 10years', 'ipdSharing': 'YES', 'description': 'We plan to share the dataset generated and analyzed in this study after publication of the results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Rania Hassan Mostafa', 'investigatorAffiliation': 'Ain Shams University'}}}}