Skip to main content
Clinical Trials/NCT03567551
NCT03567551
Completed
Not Applicable

Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B

University of Alabama at Birmingham1 site in 1 country126 target enrollmentMay 15, 2017
ConditionsPreeclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
University of Alabama at Birmingham
Enrollment
126
Locations
1
Primary Endpoint
S100B protein fragments in maternal blood plasma
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 15, 2017
End Date
September 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tekuila Carter

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Outcomes

Primary Outcomes

S100B protein fragments in maternal blood plasma

Time Frame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence

Aquaporin 4 protein fragments in maternal blood plasma

Time Frame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

Aquaporin 4 protein fragments in cerebrospinal fluid

Time Frame: At the time of spinal or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

S100B protein fragments in cord blood and placental samples

Time Frame: Between delivery and 2 hours after delivery

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

S100B protein fragments in cerebrospinal fluid

Time Frame: At the time of spinal or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

Aquaporin 4 protein fragments in cord blood and placental samples

Time Frame: Between delivery and 2 hours after delivery

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

Secondary Outcomes

  • Fatty Acids in cerebrospinal fluid(during epidural or combined spinal/epidural anesthesia)
  • Fatty acids in maternal blood(Between hospital admission and prior to epidural or combined spinal/epidural anesthesia)
  • Fatty acids in cord blood and placental samples(Between immediately post-delivery and 2 hours after delivery)

Study Sites (1)

Loading locations...

Similar Trials