NCT07478055Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Biomarkers in Management of PP Preeclampsia
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Mar 2026
- Start date
- Dec 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Alexander Harrison
- NCT number
- NCT07478055
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From Dec 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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)
Other
- Multiple gestations (twins, triplets, etc)
- Inability to consent in English
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.