Serum Magnesium Level Between Administered Rate of 2 g/hr Versus 2.5 g/hr in Severe Pre-eclampsia Obese Pregnancy, Multicentered Randomized Study
| Registry | NCT03661775 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: none, prevention |
| Enrollment | 60 (Actual) |
| Sponsor | Department of Medical Services Ministry of Public Health of Thailand (Other gov) |
| Conditions | Severe Pre-eclampsia, Magnesium Level |
| Interventions | Magnesium sulfate administration (Drug) |
| Dates | start 2018-09-30, primary completion 2018-12-30, completion 2019-05-31, first posted 2018-09-07, last updated 2020-10-12 |
| Locations | 1 site in Thailand |
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Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese
Magnesium sulfate is, generally, applied in order to alleviate or to avoid seizures. It can be administered according to many medical approaches. Nevertheless, at Rajavithi Hospital, the recommended administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour (Zudpan regimen). The therapeutic index of magnesium is in the range of 4.8-8.4 mg/dL. After that, the level of magnesium sulfate will be evaluated every 4 or 6 hours.
At Rajavithi Hospital, there are a lot of patients having pre-eclampsia symptom and many patients, who were received magnesium sulfate in the treatment, having the level of magnesium sulfate lower than the therapuetic level and needed to increase the maintenance dose to 2.5 grams/hour. Therefore, this work aims to studying the amount of magnesium sulfate administered to pregnant woman with pre-eclampsia symptom who possess high body mass index (BMI), especially for BMI greater than or equal to 30 kg/m2.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| controlled group | Experimental | Drug: Magnesium sulfate administration | controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour |
| Experimental group | Experimental | Drug: Magnesium sulfate administration | group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour |
Sex: Female, accepts healthy volunteers
Inclusion Criteria: * Pregnancy women who have MBI ≥ 31kg/m2 * Pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more. * Pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more. Exclusion Criteria: * Pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl * Pregnancy women who have contraindication to use magnesium sulfate
| Facility | City | Country | Status |
|---|---|---|---|
| Rajavithi Hospital | Bangkok | Thailand |