PreeclampsiaNCT03567551
Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B
An observational study of Preeclampsia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Women w/ Preeclampsia w/o Visual Disturbances or Headache, Women w/ Preeclampsia w/ Visual Disturbances or Headaches and Women w/o Preeclampsia
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 15 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B
This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Women w/ Preeclampsia w/o Visual Disturbances or Headache, Women w/ Preeclampsia w/ Visual Disturbances or Headaches, Women w/o Preeclampsia
- Keywords
- Preeclampsia, Pregnancy, Complications, Eclampsia, Aquaporin, Aquaporin 4
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women w/ Preeclampsia w/o Visual Disturbances or HeadacheOther
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 HeadachesOther
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 PreeclampsiaOther
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
| Study group | Role | What they receive |
|---|---|---|
| Women w/ Preeclampsia w/o Visual Disturbances or Headache | Preeclampsia Without either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110 Receives: Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache | |
| Women w/ Preeclampsia w/ Visual Disturbances or Headaches | Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110 Receives: Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches | |
| Women w/o Preeclampsia | Normal Pregnancy Blood Pressure: <140/90 Receives: Other: Women w/o Preeclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between delivery and 2 hours after delivery
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: during epidural or combined spinal/epidural anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 May 2017
- Primary completion13 Jan 2020
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tekuila Carter, University of Alabama at Birmingham
- Investigators
- Tekuila Carter, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567551
- Sponsor's protocol ID
- IRB-160822006
- Status last verified
- Jan 2022
- First submitted
- 21 May 2018
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B
- ClinicalTrials.gov ID
- NCT03567551
- Acronym / sponsor ID
- IRB-160822006
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Pregnancy, Complications, Eclampsia, Aquaporin, Aquaporin 4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women w/ Preeclampsia w/o Visual Disturbances or Headache | – | Other: Women w/ Preeclampsia w/o Visual Disturbances or HeadachePreeclampsia Without either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110 |
| Women w/ Preeclampsia w/ Visual Disturbances or Headaches | – | Other: Women w/ Preeclampsia w/ Visual Disturbances or HeadachesPreeclampsia With either Visual Disturbances or Headaches Blood Pressure: >Systolic 160 or Diastolic 110 |
| Women w/o Preeclampsia | – | Other: Women w/o PreeclampsiaNormal Pregnancy Blood Pressure: <140/90 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women w/ Preeclampsia w/o Visual Disturbances or HeadacheUp 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 | Other | Women w/ Preeclampsia w/o Visual Disturbances or Headache |
| Women w/ Preeclampsia w/ Visual Disturbances or HeadachesUp 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 | Other | Women w/ Preeclampsia w/ Visual Disturbances or Headaches |
| Women w/o PreeclampsiaUp 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 | Other | Women w/o Preeclampsia |
Primary outcome
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
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
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
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
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
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
3 secondary outcomes
Fatty acids in maternal blood
Time frame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia
Fatty acids in cord blood and placental samples
Time frame: Between immediately post-delivery and 2 hours after delivery
Fatty Acids in cerebrospinal fluid
Time frame: during epidural or combined spinal/epidural anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tekuila Carter, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aquaporin 4 protein fragments in maternal blood plasma (time frame: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.