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Completed

NCT Number: NCT03567551

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

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

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Women w/ Preeclampsia w/o Visual Disturbances or Headache

Other

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

Other

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

Other

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

Primary outcomes

  1. Aquaporin 4 protein fragments in maternal blood plasma

    Time frame: 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

  2. S100B protein fragments in maternal blood plasma

    Time frame: 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

  3. Aquaporin 4 protein fragments in cerebrospinal fluid

    Time frame: 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

  4. S100B protein fragments in cerebrospinal fluid

    Time frame: 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

  5. Aquaporin 4 protein fragments in cord blood and placental samples

    Time frame: 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

  6. S100B protein fragments in cord blood and placental samples

    Time frame: 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 outcomes

  1. Fatty acids in maternal blood

    Time frame: 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

  2. Fatty acids in cord blood and placental samples

    Time frame: 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

  3. Fatty Acids in cerebrospinal fluid

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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