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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2021-09-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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/o Visual Disturbances or Headache

Intervention Type 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

Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: \>Systolic 160 or Diastolic 110

Women w/ Preeclampsia w/ Visual Disturbances or Headaches

Intervention Type 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

Normal Pregnancy Blood Pressure: \<140/90

Women w/o Preeclampsia

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes