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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567551
• Other study ID #: IRB-160822006
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: September 15, 2021

Study information

• Verified date: January 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 15, 2021
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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
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
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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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