Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

Not Applicable

Completed

• Conditions: Severe Pre-eclampsia; Magnesium Level
• Interventions: Drug: Magnesium sulfate administration

• Registration Number: NCT03661775
• Lead Sponsor: Rajavithi Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-14
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-09-30
• Primary Completion: 2018-12-30
• Study Completion: 2019-05-31
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental group	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
controlled group	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

Primary Outcome Measures

Name	Time	Method
therapeutic level	4 hours after infusion magnesium sulfate	Serum magnesium level

Secondary Outcome Measures

Name	Time	Method
Outcome of pregnancy	24 hours after delivery	maternal and fetal outcome

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand