Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B
1 other identifier
observational
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedJanuary 21, 2022
January 1, 2022
2.7 years
May 21, 2018
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Aquaporin 4 protein fragments in maternal blood plasma
The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence
Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
S100B protein fragments in maternal blood plasma
The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence
Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
Aquaporin 4 protein fragments in cerebrospinal fluid
The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence
At the time of spinal or combined spinal/epidural anesthesia
S100B protein fragments in cerebrospinal fluid
The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence
At the time of spinal or combined spinal/epidural anesthesia
Aquaporin 4 protein fragments in cord blood and placental samples
The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence
Between delivery and 2 hours after delivery
S100B protein fragments in cord blood and placental samples
The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence
Between delivery and 2 hours after delivery
Secondary Outcomes (3)
Fatty acids in maternal blood
Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
Fatty acids in cord blood and placental samples
Between immediately post-delivery and 2 hours after delivery
Fatty Acids in cerebrospinal fluid
during epidural or combined spinal/epidural anesthesia
Study Arms (3)
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/ Visual Disturbances or Headaches
Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: \>Systolic 160 or Diastolic 110
Women w/o Preeclampsia
Normal Pregnancy Blood Pressure: \<140/90
Interventions
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
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
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tekuila Carter, MD
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 21, 2018
First Posted
June 26, 2018
Study Start
May 15, 2017
Primary Completion
January 13, 2020
Study Completion
September 15, 2021
Last Updated
January 21, 2022
Record last verified: 2022-01