Magnesium Sulfate for Pre-eclampsia
What You Need to Know Before You Apply
What is the purpose of this trial?
Participants are recruited for a research study about how lab values change following delivery in people with Preeclampsia with Severe Features. Preeclampsia with Severe Features means that the disease has impacted organs, causing high blood pressures, symptoms, or changes in lab values. Those with Preeclampsia with Severe Features receive magnesium sulfate after delivery.
The study is intended to learn how lab values change following delivery and to investigate how quickly participants get better from preeclampsia. Participation in this research will last while admitted to the hospital. Information will be collected from the post partum visit, but there is no need for blood draw at that time. The purpose of this research is to gather information on the safety and effectiveness of a shorter administration of magnesium which is approved by the Food and Drug Administration (FDA).
Participants will be randomized into two groups, which means that it will be decided by chance if 12 hours or 24 hours of magnesium will be given after the delivery of the baby.
Blood samples will be collected at time of delivery, 12 hours after delivery, 18 hours after delivery, 24 hours after delivery, and then daily. This is very similar to the number of labs to be collected even if participants decide not to participate in this study. This would likely add 2 or 3 blood draws. Both groups will have the same number of blood draws collected.
Other than possibly having 12 hours of magnesium, and a few more blood draws, the rest of the care received will not change. Each blood draw will consist of \~10mL, meaning a total of about 40mL of blood would be drawn for the purpose of this study.
Data would be collected, and deidentified. Information collected would include age, other medical conditions (like diabetes or high blood pressure out side of pregnancy), blood pressure, and symptoms during hospital stay and at the post partum visit.
Who Is on the Research Team?
John O'Brien, MD
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive magnesium sulfate administration post-partum for either 12 or 24 hours, with blood samples collected at specified intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment, including chart review until 6 weeks post-partum
What Are the Treatments Tested in This Trial?
Interventions
- Magnesium Sulfate
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
This arm would receive 12 hours of post partum magnesium sulfate administration
This arm would receive the typical 24 hours of post partum magnesium sulfate administration
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexander Harrison
Lead Sponsor
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