Magnesium Sulfate in Obese Preeclamptics

Preeclampsia Clinical Trial

Official title:

Randomized Trial of Magnesium Sulfate in Obese Preeclamptic Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835339
• Other study ID #: OHSU IRB 15809
• Status: Completed
• Phase: Phase 4
• Start date: July 12, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Magnesium sulfate 4g loading dose, 1g/hr infusion

• Magnesium sulfate 6g loading dose, 2g/hr infusion

Locations

Country	Name	City	State
United States	Oregon Health & Science Univerity	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Serum Magnesium Level at 4 Hours After Administration	magnesium level in mg/dL	4 hours
Secondary	Maternal Serum Magnesium Level at Time of Delivery	magnesium level in mg/dL	Within 20 minutes of delivery
Secondary	Maternal Side Effects	Presence or absence of the following: flushing, lethargy, palpitations, pain at IV site, respiratory depression	4 hours