Magnesium Sulfate in Obese Preeclamptics

Phase 4

Completed

• Conditions: Preeclampsia
• Interventions: Drug: Magnesium sulfate 6g loading dose, 2g/hr infusion; Drug: Magnesium sulfate 4g loading dose, 1g/hr infusion

• Registration Number: NCT02835339
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-07
• Study Start: 2016-07-12
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Results First Submitted: 2020-04-22
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Results First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MgSO4 6g load, 2g/hr infusion	Magnesium sulfate 6g loading dose, 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.
MgSO4 4g load, 1g/hr infusion	Magnesium sulfate 4g loading dose, 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.

Primary Outcome Measures

Name	Time	Method
Maternal Serum Magnesium Level at 4 Hours After Administration	4 hours	magnesium level in mg/dL

Secondary Outcome Measures

Name	Time	Method
Maternal Serum Magnesium Level at Time of Delivery	Within 20 minutes of delivery	magnesium level in mg/dL
Maternal Side Effects	4 hours	Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression

Trial Locations

Locations (1)

Oregon Health & Science Univerity; 🇺🇸 Portland, Oregon, United States