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Biomarkers in Management of Post Partum Preeclampsia

Biomarkers in Management of PP Preeclampsia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 would likely add 2 or 3 blood draws."
  • "Both groups will have the same number of blood draws collected."
  • "Each blood draw will consist of \~10mL, meaning a total of about 40mL of blood would be drawn for the purpose of this study."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares 12 hours with 24 hours of magnesium sulfate after birth in people with severe preeclampsia, a pregnancy condition that causes high blood pressure and can harm organs. It checks lab results and recovery to learn whether the shorter treatment is safe and works well. The treatment group is chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 45 years old.
  • Are pregnant and giving birth with severe preeclampsia.
  • Have severe preeclampsia confirmed by standard medical rules, based on lasting symptoms, abnormal blood tests, or very high blood pressure.

Who can't join

  • Have HELLP syndrome, which damages red blood cells and the liver and lowers platelets, the cells that help blood clot.
  • Have fluid in the lungs.
  • Have short-term or long-term kidney injury.
  • Have eclampsia, which means seizures linked to preeclampsia.
  • Have worsening symptoms involving the brain or nerves.
  • Have a medical condition that makes magnesium unsafe, such as myasthenia gravis, a disease that causes muscle weakness.
  • Are pregnant with twins, triplets, or more babies.
  • Cannot give consent in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

KY