Biomarkers in Management of Post Partum Preeclampsia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAlexander Harrison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Magnesium Sulfate
DrugThe experimental group will receive 12 hours of magnesium sulfate post partum, as compared to the control group which will receive 24 hour administration
Magnesium Sulfate
DrugThe control arm will receive 24 hours of magnesium sulfate administration post partum
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard of CareActive comparator 1 intervention
Group B: 12 hour administration groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day of delivery through discharge (up to 4 days)2
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.
Time frame
Day of delivery through discharge (up to 4 days)3
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.
Time frame
Day of delivery through discharge (up to 4 days)4
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.
Time frame
Day of delivery through discharge (up to 4 days)Secondary outcomes
1
Change in systolic blood pressure
Measured as millimeter of mercury (mmHg).
Time frame
Time of delivery through post partum visit (up to 6 weeks)2
Change in diastolic blood pressure
Measured as millimeter of mercury (mmHg).
Time frame
Time of delivery through post partum visit (up to 6 weeks)3
Change in mean arterial pressure
Measured as millimeter of mercury (mmHg).
Time frame
Time of delivery through post partum visit (up to 6 weeks)4
Change in pulse rate
Measured in beats per minute (beats/min).
Time frame
Time of delivery through post partum visit (up to 6 weeks)Other outcomes
1
1 minute APGAR Scores
APGAR scores (1 being lowest, 9 being highest)
Time frame
1 minute following delivery2
5 minute APGAR Score
APGAR scores (1 being lowest, 9 being highest)
Time frame
5 minutes following delivery3
10 minute APGAR Score
APGAR scores (1 being lowest, 9 being highest)
Time frame
10 minutes following delivery4
Gestational Age At Delivery
Gestational Age At Delivery (measured in weeks and decimal point to represent days)
Time frame
At time of deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Alexander Harrison
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov
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