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Novel Biomarkers of Preeclampsia

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ClinicalTrials.gov Identifier: NCT03567551
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tekuila Carter, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Preeclampsia Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches Other: Women w/o 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.

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Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Women w/ Preeclampsia w/o Visual Disturbances or Headache
Preeclampsia Without either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110
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
Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110
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

Women w/o Preeclampsia
Normal Pregnancy Blood Pressure: <140/90
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




Primary Outcome Measures :
  1. To evaluate the biomarker Aquaporin 4's presence or absence in women with pre-eclampsia [ 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. To evaluate the biomarker S100B's presence or absence in women with pre-eclampsia [ 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. To evaluate the biomarker Aquaporin 4's presence or absence in women with pre-eclampsia [ 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. To evaluate the biomarker S100B's presence or absence in women with pre-eclampsia [ 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. To evaluate the biomarker Aquaporin 4's presence or absence in women with pre-eclampsia [ 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. To evaluate the biomarker S100B's presence or absence in women with pre-eclampsia [ 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

  7. To evaluate the biomarker Aquaporin 4's presence or absence in women with pre-eclampsia [ Time Frame: Between delivery and 72 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

  8. To evaluate the biomarker S100B's presence or absence in women with pre-eclampsia [ Time Frame: Between delivery and 72 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 Outcome Measures :
  1. To evaluate the presence of fatty acids and how this possible presence relates to the mechanism of Preeclampsia [ 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. To evaluate the presence of fatty acids and how this possible presence relates to the mechanism of Preeclampsia [ 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

  3. To evaluate the presence of fatty acids and how this possible presence relates to the mechanism of Preeclampsia [ 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

  4. To evaluate the presence of fatty acids and how this possible presence relates to the mechanism of Preeclampsia [ Time Frame: Between delivery and 72 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567551


Contacts
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Contact: Adam Sturdivant, MPH 205-934-4042 Adamsturdivant@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Adam B Sturdivant, MPH         
Principal Investigator: Tekuila Carter, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Tekuila Carter, MD University of Alabama at Birmingham

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Responsible Party: Tekuila Carter, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03567551     History of Changes
Other Study ID Numbers: IRB-160822006
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tekuila Carter, University of Alabama at Birmingham:
Preeclampsia
Pregnancy
Complications
Eclampsia
Aquaporin
Aquaporin 4

Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications