Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 152 for:    severe preeclampsia AND Pregnancy Complications

Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661775
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Severe Pre-eclampsia Magnesium Level Drug: Magnesium sulfate administration Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Factorial 2-by-2 open labeled randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018


Arm Intervention/treatment
Experimental: 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
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

Experimental: 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
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




Primary Outcome Measures :
  1. therapeutic level [ Time Frame: 4 hours after infusion magnesium sulfate ]
    Serum magnesium level


Secondary Outcome Measures :
  1. Outcome of pregnancy [ Time Frame: 24 hours after delivery ]
    maternal and fetal outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661775


Contacts
Layout table for location contacts
Contact: Ratriya Panyawachirasophon, M.D. 0868364432 miraclenany@hotmail.com

Locations
Layout table for location information
Thailand
Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital

Layout table for additonal information
Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03661775     History of Changes
Other Study ID Numbers: RJMAG001
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents