Biomarkers in Management of Post Partum Preeclampsia

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Alexander Harrison
Study ID
NCT07478055
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Preeclampsia Postpartum
  • Preeclampsia Severe

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnesium Sulfate — DRUG
    The experimental group will receive 12 hours of magnesium sulfate post partum, as compared to the control group which will receive 24 hour administration
  • Magnesium Sulfate — DRUG
    The control arm will receive 24 hours of magnesium sulfate administration post partum

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    This arm would receive the typical 24 hours of post partum magnesium sulfate administration
  • Experimental: 12 hour administration group
    This arm would receive 12 hours of post partum magnesium sulfate administration

Primary Outcome Measure

Change in creatinine [ Time Frame: Day of delivery through discharge (up to 4 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Alexander M Harrison, MD
[email protected]
859-257-5158

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By research site
University of Kentucky· Lexington, KY

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