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

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

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

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache; Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches; Other: Women w/o 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.

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women older than 20 years of age, who meet all inclusion criteria and none of the exclusion criteria, and who are willing and able to sign informed consent documentation, as well as receive a combined spinal/epidural, or a spinal anesthesia regimen.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women w/ Preeclampsia w/o Visual Disturbances or Headache; Preeclampsia Without either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110	Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache; Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant
Women w/ Preeclampsia w/ Visual Disturbances or Headaches; Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110	Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches; Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant
Women w/o Preeclampsia; Normal Pregnancy Blood Pressure: <140/90	Other: Women w/o Preeclampsia; Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aquaporin 4 protein fragments in maternal blood plasma	The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence	Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
S100B protein fragments in maternal blood plasma	The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence	Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
Aquaporin 4 protein fragments in cerebrospinal fluid	The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence	At the time of spinal or combined spinal/epidural anesthesia
S100B protein fragments in cerebrospinal fluid	The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence	At the time of spinal or combined spinal/epidural anesthesia
Aquaporin 4 protein fragments in cord blood and placental samples	The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence	Between delivery and 2 hours after delivery
S100B protein fragments in cord blood and placental samples	The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence	Between delivery and 2 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatty acids in maternal blood	The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence	Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
Fatty acids in cord blood and placental samples	The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence	Between immediately post-delivery and 2 hours after delivery
Fatty Acids in cerebrospinal fluid	The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence	during epidural or combined spinal/epidural anesthesia

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Tekuila Carter, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ACTUAL): January 13, 2020
• Study Completion (ACTUAL): September 15, 2021

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Complications; Preeclampsia; Eclampsia; Aquaporin; Aquaporin 4
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: IRB-160822006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No