An observational study in Preeclampsia, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by University of Alabama at Birmingham · Observational
This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.
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.
904 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 126 is below the median of 160 across 389 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Alabama at Birmingham is the lead sponsor of 1,416 studies on the registry; 278 are open to participants now.
Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Preeclampsia Without either Visual Disturbances or Headaches Blood Pressure: \>Systolic 160 or Diastolic 110
Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache
Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: \>Systolic 160 or Diastolic 110
Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Between delivery and 2 hours after delivery
Fatty acids in maternal blood
The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence
Time frame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
Fatty acids 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
Time frame: Between immediately post-delivery and 2 hours after delivery
Fatty Acids 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
Time frame: during epidural or combined spinal/epidural anesthesia
Ran from May 2017 to primary completion in Jan 2020, 31 months.
Of 187 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 31 months is above that.
Counting every sponsor, half of 195 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →