Biomarkers in Management of Post Partum Preeclampsia

NCT07478055 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 108288
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Preeclampsia Severe; Preeclampsia Postpartum

Keywords

PreEclampsia; Magnesium Sulfate; Post Partum; PreEclampsia with Severe Features

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• Change in systolic blood pressure

  Time of delivery through post partum visit (up to 6 weeks)

• Change in diastolic blood pressure

  Time of delivery through post partum visit (up to 6 weeks)

• Change in mean arterial pressure

  Time of delivery through post partum visit (up to 6 weeks)

• Change in pulse rate

  Time of delivery through post partum visit (up to 6 weeks)

• Change in urine output

  Time of delivery through post partum visit (up to 6 weeks)

Other Outcomes (14)

• 1 minute APGAR Scores

  1 minute following delivery

• 5 minute APGAR Score

  5 minutes following delivery

• 10 minute APGAR Score

  10 minutes following delivery

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

This arm would receive the typical 24 hours of post partum magnesium sulfate administration

Drug: Magnesium Sulfate

12 hour administration group

EXPERIMENTAL

This arm would receive 12 hours of post partum magnesium sulfate administration

Drug: Magnesium Sulfate

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

12 hour administration group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Multiple gestations (twins, triplets, etc)
• Inability to consent in English

Sponsors & Collaborators

• Alexander Harrison: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• John O'Brien, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander M Harrison, MD

CONTACT

859-257-5158; alexander.harrison@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The available information will be accessible at start of study, and remain available through publication
• Access Criteria: Those who request from the study PI will be considered for access

Locations

US (1)