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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03567551
Enrollment
126
Registered
2018-06-26
Start date
2017-05-15
Completion date
2021-09-15
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, Pregnancy, Complications, Eclampsia, Aquaporin, Aquaporin 4

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.

Interventions

OTHERWomen 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

OTHERWomen 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

OTHERWomen 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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
S100B protein fragments in cord blood and placental samplesBetween delivery and 2 hours after deliveryThe 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 fluidAt the time of spinal or combined spinal/epidural anesthesiaThe 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 fluidAt the time of spinal or combined spinal/epidural anesthesiaThe 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 samplesBetween delivery and 2 hours after deliveryThe 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 plasmaBetween hospital admission and prior to epidural or combined spinal/epidural anesthesiaThe 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 plasmaBetween hospital admission and prior to epidural or combined spinal/epidural anesthesiaThe investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence

Secondary

MeasureTime frameDescription
Fatty acids in cord blood and placental samplesBetween immediately post-delivery and 2 hours after deliveryThe 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 cerebrospinal fluidduring epidural or combined spinal/epidural anesthesiaThe 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 bloodBetween hospital admission and prior to epidural or combined spinal/epidural anesthesiaThe investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026