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

Completed

• Conditions: Preeclampsia
• Interventions: Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache; Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches; Other: Women w/o Preeclampsia

• Registration Number: NCT03567551
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-26
• Primary Completion: 2020-01-13
• Study Completion: 2021-09-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Aquaporin 4 protein fragments in maternal blood plasma	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
S100B protein fragments in maternal blood plasma	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	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	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	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	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 Outcome Measures

Name	Time	Method
Fatty Acids in cerebrospinal fluid	during 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
Fatty acids in maternal blood	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
Fatty acids in cord blood and placental samples	Between immediately post-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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States