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Completed

NCT Number: NCT02835339

Magnesium Sulfate in Obese Preeclamptics

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science Univerity

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate 4g loading dose, 1g/hr infusion

Drug

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

Drug

Primary outcomes

  1. Maternal Serum Magnesium Level at 4 Hours After Administration

    Time frame: 4 hours

    magnesium level in mg/dL

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Randomized Trial of Magnesium Sulfate in Obese Preeclamptic Women

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2016
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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