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Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

Serum Magnesium Level Between Administered Rate of 2 g/hr Versus 2.5 g/hr in Severe Pre-eclampsia Obese Pregnancy, Multicentered Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03661775
Enrollment
60
Registered
2018-09-07
Start date
2018-09-30
Completion date
2019-05-31
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Pre-eclampsia, Magnesium Level

Brief summary

Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese

Detailed description

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.

Interventions

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 : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour

Sponsors

Department of Medical Services Ministry of Public Health of Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Factorial 2-by-2 open labeled randomised controlled trial

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
therapeutic level4 hours after infusion magnesium sulfateSerum magnesium level

Secondary

MeasureTime frameDescription
Outcome of pregnancy24 hours after deliverymaternal and fetal outcome

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026