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Completed

NCT Number: NCT03661775

Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

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

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Key information

Conditions

Severe Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Magnesium Level Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate administration

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

Primary outcomes

  1. therapeutic level

    Time frame: 4 hours after infusion magnesium sulfate

    Serum magnesium level

Secondary outcomes

  1. Outcome of pregnancy

    Time frame: 24 hours after delivery

    maternal and fetal outcome

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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