[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553433":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":33,"overallOfficials":13,"centralContacts":43,"locations":13,"responsibleParty":49,"collaborators":13,"id":51,"slug":13,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":13,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":13,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":13,"overallStatus":70,"whyStopped":13,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":13},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"serum magnesium level","Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion","24 hours",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Magnesium sulfate is used in pre-eclampsia to prevent seizures, it is administered in the form of a loading dose and maintenance dose. Maintenance dose of magnesium sulfate in pre-eclampsia varies in literature (1-3gms\u002Fhour). There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level. This study will evaluate whether overweight and obese women need higher maintenance doses to reach therapeutic level of magnesium sulfate in serum.Preeclampsia is a serious pregnancy complication characterized by hypertension, proteinuria and signs of damage to another organ system, often the kidneys, occurring after 20 weeks of gestation",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"Magnesium Sulphate 1g\u002Fhr","ACTIVE_COMPARATOR","Women in this group will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 1 g\u002Fh.",[27],"Drug: maintenance magnesium sulphate1g\u002Fh",{"label":29,"type":24,"description":30,"interventionNames":31},"Magnesium Sulphate 2g\u002Fhr","Women in this group will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 2 g\u002Fh.",[32],"Drug: maintenance magnesium sulphate2g\u002Fh",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":13},"DRUG","maintenance magnesium sulphate1g\u002Fh","Women will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 1 g\u002Fh.",[23],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"maintenance magnesium sulphate2g\u002Fh","Women will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 2 g\u002Fh.",[29],[44],{"name":45,"role":46,"phone":47,"phoneExt":13,"email":48},"Rehab Hashem","CONTACT","01017830916","rehabhashem66@gmail.com",{"type":50,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100553433",false,"NCT06486025","Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia","ALTERNATE DOSING PROTOCOL FOR MAGNESIUM SULFATE IN OVERWEIGHT AND OBESE WOMEN WITH PREECLAMPISA: A RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\nWomen diagnosed with SPET as per criteria of NICE, 2023 guidance\n\n* Age 20-40 years\n* BMI \\>25kg\u002Fm2\n* Gestational age \\> 28 weeks\n\nExclusion Criteria:\n\n* Intrauterine Fetal Death (IUFD)\n* Hemolysis - Elevated liver enzymes - Low platelets syndrome (HELLP)\n* Contraindication to Magnesium Sulfate such as myasthenia gravis, severe renal failure, cardiac ischemia, and heart block\n* Serum creatinine levels greater than 1.1 mg\u002FdL.\n* Women refusing to participate in the study.","FEMALE","20 Years","40 Years",{"count":61,"type":62},100,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.",[69],"Severe Preeclampsia","NOT_YET_RECRUITING","2024-06-27",{"date":73,"type":74},"2024-07-03","ACTUAL",{"date":76,"type":62},"2024-07-01",{"date":78,"type":62},"2024-10-01",{"name":5,"class":6}]