Biomarkers in Management of Post Partum Preeclampsia

Biomarkers in Management of PP Preeclampsia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia Postpartum; Preeclampsia Severe
• Intervention / Treatment: Drug: Magnesium Sulfate; Drug: Magnesium Sulfate

Detailed 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 will consist of participants with preeclampsia with severe features randomized to 24 hours of magnesium administration post-partum.

After their initial enrollment, care will not be impacted leading up to the delivery of the neonate. Following delivery, the magnesium sulfate administration will remain a continuous infusion at 2 grams per hour (diluted in lactated ringers for total infusion volume of 50mL per hour) as is standard practice. Care for both groups will remain as standard for nursing monitoring including exam and vital signs at least hourly while on magnesium sulfate continuous infusion.

Both groups at completion of magnesium sulfate, either 12 hours after delivery for the intervention group or 24 hours after delivery for control group, will continue with standard monitoring procedures per institutional protocol.

Both groups will have blood (serum) analysis collected at time of delivery, 12 hours later, then at 18 hours following delivery, and 24 hours. After 24 hours of collection, the lab evaluation will be spaced to daily until discharge. While laboratory evaluation, being collected and analyzed, every 6 hours is a standard practice for many clinical circumstances while admitted for pre-eclampsia with severe features, there is the potential to increased cost if not felt to be clinically indicated post-partum. This cost would not be passed along to patients and would instead be covered by funding acquired for this study. Additionally, some of the serum analytes collected, such as soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) are not part of routine analysis, and costs will be covered by research funding rather than billed to patients.

Analysis will consist of typical preeclampsia markers such as liver transaminases, serum creatinine, platelet counts. Additional analytes will include sFlt-1, PlGF, intracellular adhesion molecule (ICAM), vascular cell adhesion molecule (VCAM), B-type natriuretic peptide (BNP). Clinical analysis will consist of chart analysis floor policy but will include vital signs (blood pressure, respiratory rate, oxygen saturation, pulse), standard review of systems to assess for magnesium side effects/toxicity, and other evaluation that was clinically indicated based on patient status such as imaging if necessary. No clinical interventions will be altered by study protocol other than the determination of 12-hour or 24-hour magnesium sulfate administration post-partum. Patients will receive standard postpartum outpatient follow-up. No additional clinical visits related to the study will be necessary, and chart review will be completed until 6 weeks post-partum as that is the duration in which preeclampsia is anticipated to resolve.

Per floor policy, the magnesium bolus of 4g will already have been received prior to randomization, and the standard administration rate of 2g/hr will be continued through delivery, and into the post-partum period where the study takes place. Clinicians often adjust magnesium dosing in the setting of pulmonary edema, renal dysfunction (creatinine >1.1), or if concern presents for magnesium toxicity. If these concerns present, clinician judgement to alter magnesium dosing, or length of administration, will not be influenced.

The patient will continue in the study, with necessary annotations in the data analysis to specify these findings. Similarly, hemolysis elevated liver enzymes low platelets (HELLP) syndrome, eclampsia, persistent (non-improving) neurologic symptoms like a headache or vision change, would all necessitate 24-hour administration of magnesium given the underlying severity of the disease. The patients would be analyzed in their original group with intent-to-treat analysis.

Medical records will be abstracted to collect demographic information, medical and prenatal history, treatment course, information related to delivery and neonate after birth (Birth weight, gender, APGARS and neonatal complications). The blood samples collected during the study will be stored in a locked freezer behind locked doors in the participating laboratory. All identifiable information will be removed from the samples. All information will be de-identified and assigned unique identification codes before storing the specimens. Only the bank staff will have access to the master list that links the code to participants. All coded information in a secured computer behind locked doors. All digital information will be protected with passwords/encryption. Encryption changes the information to another format to protect it from being accessed by anyone outside of the approved staff.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexander M Harrison, MD; Phone Number: 859-257-5158; Email: alexander.harrison@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky
      • Contact: Alexander M Harrison, MD; Phone Number: 859-257-5158; Email: alexander.harrison@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; This arm would receive the typical 24 hours of post partum magnesium sulfate administration	Drug: 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; Drug: Magnesium Sulfate; The control arm will receive 24 hours of magnesium sulfate administration post partum
Experimental: 12 hour administration group; This arm would receive 12 hours of post partum magnesium sulfate administration	Drug: 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; Drug: Magnesium Sulfate; The control arm will receive 24 hours of magnesium sulfate administration post partum

What is the study measuring?

Primary 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)

Secondary Outcome Measures

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 minute APGAR Scores	APGAR scores (1 being lowest, 9 being highest)	1 minute following delivery
5 minute APGAR Score	APGAR scores (1 being lowest, 9 being highest)	5 minutes following delivery
10 minute APGAR Score	APGAR scores (1 being lowest, 9 being highest)	10 minutes following delivery
Gestational Age At Delivery	Gestational Age At Delivery (measured in weeks and decimal point to represent days)	At time of delivery
Birthweight At Delivery	Newborn birthweight at delivery (grams)	At time of delivery
Need for Neonatal Intensive Care Unit (NICU) Admission	Need for NICU admission (measured as a yes/no)	During hospital admission(up to 6 days)
NICU Length of Stay	NICU length of stay (days)	During neonatal hospital admission (up until 6months)
Neonatal Complications	Measured as free response for complications while admitted to hospital/NICU (ex. need for intubation, intraventricular hemorrhage)	During neonatal hospital admission (up until 6months)
Mode of Delivery	Mode of delivery (reported as vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery)	At time of birth
Feeding Type	Feeding type (reported as breast feeding, pumping, formula feeding)	Up until 6 weeks post partum
Time until ambulation	Recorded time from delivery until documented ambulation (measured in hours)	During hospital admission (up to 6 days)
Antihypertensive medication at time of discharge	Record of antihypertensive medication (name and dose in mg) at time of discharge	During hospital admission (up to 6 days)
Antihypertensive Medication Administration at Post Partum visit (1 week)	Antihypertensive medication administration at 1 week follow up visit (medication name and dose in mg)	1 week post partum
Antihypertensive medication at post partum visit (6 weeks)	Antihypertensive medication administration at 6 week follow up visit (medication name and dose in mg)	6 weeks post partum

Collaborators and Investigators

• Sponsor: Alexander Harrison
• Investigators: Principal Investigator: John O'Brien, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Magnesium Sulfate; Post Partum; PreEclampsia; PreEclampsia with Severe Features
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Magnesium Sulfate
• Other Study ID Numbers: 108288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected variables (including screening criteria, diagnostic criteria, intervention, outcomes) will be shared, while individual patient identifiers will be removed.
• IPD Sharing Time Frame: The available information will be accessible at start of study, and remain available through publication
• IPD Sharing Access Criteria: Those who request from the study PI will be considered for access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No