Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

Severe Pre-eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661775
• Other study ID #: RJMAG001
• Status: Completed
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Magnesium Level
• Pre-Eclampsia
• Severe Pre-eclampsia

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	therapeutic level	Serum magnesium level	4 hours after infusion magnesium sulfate
Secondary	Outcome of pregnancy	maternal and fetal outcome	24 hours after delivery