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Clinical Trial NCT07478055 for Preeclampsia Severe, Preeclampsia Postpartum is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Biomarkers in Management of Post Partum Preeclampsia Phase 4 100 Biomarker-Driven Randomized
Clinical Trial NCT07478055 is designed to study Treatment for Preeclampsia Severe, Preeclampsia Postpartum. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 31 March 2026 until the study accrues 100 participants. Led by Alexander Harrison, this study is expected to complete by 31 August 2027. The latest data from ClinicalTrials.gov was last updated on 17 March 2026.
Brief Summary
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 valu...
Show MoreDetailed Description
The research procedures, including patient enrollment, will occur while admitted to the Labor and Delivery Unit at University of Kentucky Chandler Hospital prior to birth, and no additional visits for the purpose of this research are anticipated. The experimental group will include pregnant participants with preeclampsia with severe features who are randomized to 12 hours of magnesium post-partum. The control group w...Show More
Official Title
Biomarkers in Management of PP Preeclampsia
Conditions
Preeclampsia SeverePreeclampsia PostpartumOther Study IDs
- 108288
NCT ID Number
Start Date (Actual)
2026-03-31
Last Update Posted
2026-03-17
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
PreEclampsia
Magnesium Sulfate
Post Partum
PreEclampsia with Severe Features
Magnesium Sulfate
Post Partum
PreEclampsia with Severe Features
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard of Care This arm would receive the typical 24 hours of post partum magnesium sulfate administration | Magnesium Sulfate The control arm will receive 24 hours of magnesium sulfate administration post partum |
Experimental12 hour administration group This arm would receive 12 hours of post partum magnesium sulfate administration | Magnesium Sulfate The experimental group will receive 12 hours of magnesium sulfate post partum, as compared to the control group which will receive 24 hour administration |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in creatinine | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in alanine aminotransferase (ALT) | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in aspartate aminotransferase (AST) | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in sFlt-1 | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in platelets | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in PlGF | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in BNP | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in VCAM | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in ICAM | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in tumor necrosis factor-alpha (TNF-alpha) | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in Uric acid | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
Change in lactate dehydrogenase (LDH) | At time points (time of delivery, 12 hours post partum, 18 hours post partum, 24 hours post partum, then daily until discharge) serum will be analyzed for a change in biomarker levels. | Day of delivery through discharge (up to 4 days) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in systolic blood pressure | Measured as millimeter of mercury (mmHg). | Time of delivery through post partum visit (up to 6 weeks) |
Change in diastolic blood pressure | Measured as millimeter of mercury (mmHg). | Time of delivery through post partum visit (up to 6 weeks) |
Change in mean arterial pressure | Measured as millimeter of mercury (mmHg). | Time of delivery through post partum visit (up to 6 weeks) |
Change in pulse rate | Measured in beats per minute (beats/min). | Time of delivery through post partum visit (up to 6 weeks) |
Change in urine output | urine output (measured as mL/kg/hr) | Time of delivery through post partum visit (up to 6 weeks) |
Incidence of adverse outcomes | patient reported symptoms (headache (reported as Y/N), visual disturbances (reported as Y/N as well as comment on type), epigastric pain (reported as Y/N)), physical exam findings (lower extremity clonus (reported as Y/N), other concerning findings (with comments available to describe if pulmonary changes, mental status change, or changes to reflexes). | Time of delivery through post partum visit (up to 6 weeks) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
- The study population will consist of pregnant people ages 18 to 45 years old undergoing delivery in setting of preeclampsia with severe features as the experimental group and control (standard of care) groups
- Diagnosis of PreEclampsia with severe featues must be made by standard clinical guidelines based on symptoms (persistent headache not responsive to medications, persistent right upper quadrant pain not responsive to medications), laboratory values (creatinine >1.1mg/dL or twice the participants' baseline, AST or ALT > twice the upper limit of normal or twice patient's blood line, platelets <100,000), or blood pressure criteria (Systolic >160 mmHg or Diastolic >110mmHg persistent over 15 minutes such that short acting antihypertensives are required, or Systolic >160mmHg or Diastolic>110mmHg present 4 hours or more apart)
- Exclusion criteria included Hemolysis Elevated Liver enzymes Low Platelets (HELLP) Syndrome, pulmonary edema, chronic or acute kidney injury, eclampsia, worsening neurologic symptoms, medical contraindication to magnesium (ex. Myasthenia Gravis)
- Multiple gestations (twins, triplets, etc)
- Inability to consent in English
Alexander HarrisonStudy Responsible Party
Alexander Harrison, Sponsor-Investigator, Principal Investigator, University of Kentucky
Study Central Contact
Contact: Alexander M Harrison, MD, 859-257-5158, [email protected]
1 Study Locations in 1 Countries
Kentucky
University of Kentucky, Lexington, Kentucky, 40506, United States
Alexander M Harrison, MD, Contact, 859-257-5158, [email protected]