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Magnesium Sulfate in Obese Preeclamptics

Primary Purpose

Preeclampsia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Magnesium sulfate 4g loading dose, 1g/hr infusion
Magnesium sulfate 6g loading dose, 2g/hr infusion
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health & Science Univerity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MgSO4 4g load, 1g/hr infusion

MgSO4 6g load, 2g/hr infusion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maternal Serum Magnesium Level at 4 Hours After Administration
magnesium level in mg/dL

Secondary Outcome Measures

Maternal Serum Magnesium Level at Time of Delivery
magnesium level in mg/dL
Maternal Side Effects
Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression

Full Information

First Posted
July 7, 2016
Last Updated
May 4, 2020
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02835339
Brief Title
Magnesium Sulfate in Obese Preeclamptics
Official Title
Randomized Trial of Magnesium Sulfate in Obese Preeclamptic Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MgSO4 4g load, 1g/hr infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MgSO4 6g load, 2g/hr infusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate 4g loading dose, 1g/hr infusion
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate 6g loading dose, 2g/hr infusion
Primary Outcome Measure Information:
Title
Maternal Serum Magnesium Level at 4 Hours After Administration
Description
magnesium level in mg/dL
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Maternal Serum Magnesium Level at Time of Delivery
Description
magnesium level in mg/dL
Time Frame
Within 20 minutes of delivery
Title
Maternal Side Effects
Description
Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression
Time Frame
4 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Brookfield, M.D., PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science Univerity
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33156201
Citation
Brookfield KF, Tuel K, Rincon M, Vinson A, Caughey AB, Carvalho B. Alternate Dosing Protocol for Magnesium Sulfate in Obese Women With Preeclampsia: A Randomized Controlled Trial. Obstet Gynecol. 2020 Dec;136(6):1190-1194. doi: 10.1097/AOG.0000000000004137.
Results Reference
derived

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Magnesium Sulfate in Obese Preeclamptics

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