Clinical trial NCT03567551: Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B
Official title: Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
Pregnancy
Complications
Eclampsia
Aquaporin
Aquaporin 4
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Aquaporin 4 protein fragments in maternal blood plasma
timeFrame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
measure: S100B protein fragments in maternal blood plasma
timeFrame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
measure: Aquaporin 4 protein fragments in cerebrospinal fluid
timeFrame: At the time of spinal or combined spinal/epidural anesthesia
measure: S100B protein fragments in cerebrospinal fluid
timeFrame: At the time of spinal or combined spinal/epidural anesthesia
measure: Aquaporin 4 protein fragments in cord blood and placental samples
timeFrame: Between delivery and 2 hours after delivery
measure: S100B protein fragments in cord blood and placental samples
timeFrame: Between delivery and 2 hours after delivery
Secondary outcomes:
measure: Fatty acids in maternal blood
timeFrame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
measure: Fatty acids in cord blood and placental samples
timeFrame: Between immediately post-delivery and 2 hours after delivery
measure: Fatty Acids in cerebrospinal fluid
timeFrame: during epidural or combined spinal/epidural anesthesia
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tekuila Carter, MD
role: PRINCIPAL_INVESTIGATOR
References: