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Magnesium Sulfate in Obese Preeclamptics

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02835339
Recruitment Status : Completed
First Posted : July 18, 2016
Results First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kathleen Brookfield, Oregon Health and Science University

Brief Summary:
The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Magnesium sulfate 4g loading dose, 1g/hr infusion Drug: Magnesium sulfate 6g loading dose, 2g/hr infusion Phase 4

Detailed Description:

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

Magnesium sulfate is generally given to patients to protect the mother against seizures in the case of preeclampsia. Different hospitals in the United States use different doses of magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete. Participants will receive magnesium sulfate in the course of their normal clinical care whether or not they participate in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Magnesium Sulfate in Obese Preeclamptic Women
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019


Arm Intervention/treatment
Active Comparator: MgSO4 4g load, 1g/hr infusion
Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.
Drug: Magnesium sulfate 4g loading dose, 1g/hr infusion
Experimental: MgSO4 6g load, 2g/hr infusion
Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.
Drug: Magnesium sulfate 6g loading dose, 2g/hr infusion



Primary Outcome Measures :
  1. Maternal Serum Magnesium Level at 4 Hours After Administration [ Time Frame: 4 hours ]
    magnesium level in mg/dL


Secondary Outcome Measures :
  1. Maternal Serum Magnesium Level at Time of Delivery [ Time Frame: Within 20 minutes of delivery ]
    magnesium level in mg/dL

  2. Maternal Side Effects [ Time Frame: 4 hours ]
    Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women who are ages 18-45
  • 32-42 weeks' pregnant
  • Prescribed magnesium sulfate for preeclampsia
  • BMI ≥35 kg/m2

Exclusion Criteria:

  • Pregnant women < 32 weeks' pregnant
  • Women who are on dialysis

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): NCT02835339


Locations
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United States, Oregon
Oregon Health & Science Univerity
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Kathleen Brookfield, M.D., PhD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Kathleen Brookfield, Oregon Health and Science University:
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Responsible Party: Kathleen Brookfield, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02835339    
Other Study ID Numbers: OHSU IRB 15809
First Posted: July 18, 2016    Key Record Dates
Results First Posted: May 13, 2020
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
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