Back to results

Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

Primary Purpose

Severe Pre-eclampsia, Magnesium Level

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Magnesium sulfate administration

About this trial

This is an interventional prevention trial for Severe Pre-eclampsia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

controlled group

Experimental group

Arm Description

controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour

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

Outcomes

Primary Outcome Measures

therapeutic level

Serum magnesium level

Secondary Outcome Measures

Outcome of pregnancy

maternal and fetal outcome

Full Information

NCT ID

NCT03661775

First Posted

May 14, 2018

Last Updated

October 8, 2020

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03661775

Brief Title

Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

September 30, 2018 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Pre-eclampsia, Magnesium Level

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Factorial 2-by-2 open labeled randomised controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

controlled group

Arm Type

Experimental

Arm Description

controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Magnesium sulfate administration

Intervention Description

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

Primary Outcome Measure Information:

Title

therapeutic level

Description

Serum magnesium level

Time Frame

4 hours after infusion magnesium sulfate

Secondary Outcome Measure Information:

Title

Outcome of pregnancy

Description

maternal and fetal outcome

Time Frame

24 hours after delivery

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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 Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

We'll reach out to this number within 24 hrs