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Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Preeclampsia

Treatments

Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches
Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache
Other: Women w/o Preeclampsia

Study type

Observational

Funder types

Other

Identifiers

NCT03567551
IRB-160822006

Details and patient eligibility

About

This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.

Full description

There is a paucity of biomarkers to predict preeclampsia and for predicting the severity of preeclampsia. This study was designed to identify novel biomarkers for both the prediction of preeclampsia in previously normal pregnancies and for the prediction of the severity of preeclampsia in preeclamptic women. The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence and the investigators also plan testing for novel markers using various approaches such as proteomics, lipidomics and genomics. The targeted markers will include Aquaporin 4 (AQP4), soluble aquaporin fragments, chemokines, and halogenated fatty acids in the plasma and/or spinal fluid. Aquaporin fragments and AQP4 have been hypothesized to correlate with severe headaches which are complications of severe preeclampsia. The investigators found in their murine studies that there is a correlation between the presence of halogenated fatty acids in the plasma and elevated blood pressure in a murine model of preeclampsia. The approaches will complement the targeted analyses to identify novel markers that have not been predicted yet.

Enrollment

126 patients

Sex

Female

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Greater than or equal to 20 years of age
  • Greater than 24 weeks of gestation
  • Obstetrics/Anesthesia Team had decided that Combined Spinal/Epidural (CSE) or Spinal Anesthesia will be performed

Exclusion criteria

  • Pre-pregnancy comorbidities:
  • hypertension, diabetes, or pulmonary hypertension
  • use of steroids, beta blockers, Ca channel antagonist, anticoagulants
  • cardiac or vascular conditions
  • severe headaches or visual disturbances
  • Inability to receive CSE or Spinal Anesthesia
  • Chorioamnionitis, fever, bronchitis, pneumonia

Trial design

126 participants in 3 patient groups

Women w/ Preeclampsia w/o Visual Disturbances or Headache
Description:
Preeclampsia Without either Visual Disturbances or Headaches Blood Pressure: \>Systolic 160 or Diastolic 110
Treatment:
Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache
Women w/ Preeclampsia w/ Visual Disturbances or Headaches
Description:
Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: \>Systolic 160 or Diastolic 110
Treatment:
Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches
Women w/o Preeclampsia
Description:
Normal Pregnancy Blood Pressure: \<140/90
Treatment:
Other: Women w/o Preeclampsia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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