Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

NCT ID: NCT03661775

Last Updated: 2020-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Severe Pre-eclampsia Magnesium Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Factorial 2-by-2 open labeled randomised controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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controlled group

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 Type EXPERIMENTAL

Magnesium sulfate administration

Intervention Type DRUG

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

Experimental group

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

Group Type EXPERIMENTAL

Magnesium sulfate administration

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

Reference Type DERIVED
PMID: 37815037 (View on PubMed)

Other Identifiers

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RJMAG001

Identifier Type: -

Identifier Source: org_study_id

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