Pre-EclampsiaNCT03863639
Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia
An observational study of Pre-Eclampsia and Neurocognitive Dysfunction, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study assessing fMRI changes and neurocognitive function in women with pre-eclampsia and healthy controls. Neurocognitive testing will be done during pregnancy and after delivery up to 2-6 weeks postpartum. fMRI will be done after delivery up to 2-6 weeks postpartum. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Neurocognitive Dysfunction
- What is being tested?
- Neuroimaging Procedures and Neuropsychological Assessment Procedures
- Type of treatment
- Pill or oral medicine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2014to 13 Apr 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients with severe pre-eclampsia on the labor and delivery ward and healthy controls presenting to the antenatal clinic or the labor ward will be screened. 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age will be enrolled from the antenatal clinic or the labor ward.
Who may be able to join
- Symptoms of central nervous system dysfunction (New onset cerebral or visual disturbance, such as: Photopsia, scotomata, cortical blindness, retinal vasospasm)
- Severe headache (ie, incapacitating, "the worst headache I've ever had") or headache that persists and progresses despite analgesic therapy
- Altered mental status
- Hepatic abnormality (Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by an alternative diagnosis or serum transaminase concentration ≥ twice normal, or both)
- Severe blood pressure elevation (Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on two occasions at least four hours apart while the patient is on bedrest (unless the patient is on antihypertensive therapy))
- Thrombocytopenia (<100,000 platelets/microL)
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- Renal abnormality (Progressive renal insufficiency (serum creatinine >1.1 mg/dL or doubling of serum creatinine concentration in the absence of other renal disease))
- Pulmonary edema
- 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age will be enrolled from the antenatal clinic or the labor ward.
Who cannot join
- History of symptomatic cerebrovascular disease with substantial residual deficit
- History of alcoholism
- History of psychiatric illness
- History of claustrophobia
- Renal failure (creatinine > 2.0 mg/dl)
- Patients with less than a 7th grade education or unable to read and thus unable complete the neuropsychological testing
- Patients with bodily implants unsafe for MRI use
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
This is a pilot study assessing fMRI changes and neurocognitive function in women with pre-eclampsia and healthy controls. Neurocognitive testing will be done during pregnancy and after delivery up to 2-6 weeks postpartum. fMRI will be done after delivery up to 2-6 weeks postpartum. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population.
- Conditions
- Pre-Eclampsia, Neurocognitive Dysfunction
- Being tested
- Neuroimaging Procedures, Neuropsychological Assessment Procedures
- Keywords
- Pre-Eclampsia, Functional Magnetic Resonance Imaging, Neurocognitive Function
- Medical subject headings
- Pre-Eclampsia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroimaging ProceduresDiagnostic test
Subjects will complete neuroimaging procedures at 2-6-week postpartum or during hospitalization after delivery prior to discharge, which will consist of high-resolution anatomic, perfusion and resting-brain fMRI sequences; all of which will be acquired on a 3-Tesla General Electric magnetic resonance scanner
provided by the Brain Imaging and Analysis Center (BIAC) at Duke University. No contrast agent will be administered in these imaging procedures.
Neuropsychological Assessment ProceduresDiagnostic test
Once identified as meeting study criteria and consented for participation, parturients will be tested during hospitalization or as outpatients for controls, and at 2-6 weeks postpartum with the following cognitive battery. Wechsler Test of Adult Reading (WTAR), CANTABeclipse Computerized Cognitive Assessment Measures, Stroop Color-Word Test, Controlled Oral Word Association Test, EuroQol, Beck Depression Inventory Revised
| Study group | Role | What they receive |
|---|---|---|
| Pre-Eclampsia | 15 English-speaking women with severe pre-eclampsia Receives: Diagnostic Test: Neuroimaging Procedures; Diagnostic Test: Neuropsychological Assessment Procedures | |
| Control | 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age Receives: Diagnostic Test: Neuroimaging Procedures; Diagnostic Test: Neuropsychological Assessment Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of white matter lesions
DTI white matter patency in women with pre-eclampsia/eclampsia.
Measured: Postpartum (2-6 weeks or while hospitalized)
Classification of white matter lesions
Classify the nature of co-morbid DTI white matter patency/lesions
Measured: Postpartum (2-6 weeks or while hospitalized)
Neurocognitive Function Scores
Scores from the neurocognitive testing combined to give overall score for function.
Measured: Up to 1 day before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start7 Jul 2014
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Why it stopped: Challenging enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf S Habib, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863639
- Sponsor's protocol ID
- Pro00055293
- Status last verified
- Jun 2022
- First submitted
- 4 Mar 2019
- Last updated
- 29 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
- ClinicalTrials.gov ID
- NCT03863639
- Acronym / sponsor ID
- Pro00055293
- Conditions
- Pre-Eclampsia, Neurocognitive Dysfunction
- Keywords
- Pre-Eclampsia, Functional Magnetic Resonance Imaging, Neurocognitive Function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Challenging enrollment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Jul 2014 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 5 Mar 2019 (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 pilot study assessing fMRI changes and neurocognitive function in women with pre-eclampsia and healthy controls. Neurocognitive testing will be done during pregnancy and after delivery up to 2-6 weeks postpartum. fMRI will be done after delivery up to 2-6 weeks postpartum. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Eclampsia | – | Diagnostic Test: Neuroimaging Procedures, Diagnostic Test: Neuropsychological Assessment Procedures15 English-speaking women with severe pre-eclampsia |
| Control | – | Diagnostic Test: Neuroimaging Procedures, Diagnostic Test: Neuropsychological Assessment Procedures15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients with severe pre-eclampsia on the labor and delivery ward and healthy controls presenting to the antenatal clinic or the labor ward will be screened. 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age will be enrolled from the antenatal clinic or the labor ward.
Key inclusion criteria (9 listed)
- Symptoms of central nervous system dysfunction (New onset cerebral or visual disturbance, such as: Photopsia, scotomata, cortical blindness, retinal vasospasm)
- Severe headache (ie, incapacitating, "the worst headache I've ever had") or headache that persists and progresses despite analgesic therapy
- Altered mental status
- Hepatic abnormality (Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by an alternative diagnosis or serum transaminase concentration ≥ twice normal, or both)
- Severe blood pressure elevation (Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on two occasions at least four hours apart while the patient is on bedrest (unless the patient is on antihypertensive therapy))
Key exclusion criteria (7 listed)
- History of symptomatic cerebrovascular disease with substantial residual deficit
- History of alcoholism
- History of psychiatric illness
- History of claustrophobia
- Renal failure (creatinine > 2.0 mg/dl)
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 |
|---|---|---|
| Neuroimaging ProceduresSubjects will complete neuroimaging procedures at 2-6-week postpartum or during hospitalization after delivery prior to discharge, which will consist of high-resolution anatomic, perfusion and resting-brain fMRI sequences; all of which will be acquired on a 3-Tesla General Electric magnetic resonance scanner provided by the Brain Imaging and Analysis Center (BIAC) at Duke University. No contrast agent will be administered in these imaging procedures. | Diagnostic test | Control, Pre-Eclampsia |
| Neuropsychological Assessment ProceduresOnce identified as meeting study criteria and consented for participation, parturients will be tested during hospitalization or as outpatients for controls, and at 2-6 weeks postpartum with the following cognitive battery. Wechsler Test of Adult Reading (WTAR), CANTABeclipse Computerized Cognitive Assessment Measures, Stroop Color-Word Test, Controlled Oral Word Association Test, EuroQol, Beck Depression Inventory Revised | Diagnostic test | Control, Pre-Eclampsia |
Primary outcome
Number of white matter lesions
Time frame: Postpartum (2-6 weeks or while hospitalized)
DTI white matter patency in women with pre-eclampsia/eclampsia.
Classification of white matter lesions
Time frame: Postpartum (2-6 weeks or while hospitalized)
Classify the nature of co-morbid DTI white matter patency/lesions
Neurocognitive Function Scores
Time frame: Up to 1 day before delivery
Scores from the neurocognitive testing combined to give overall score for function.
Results and safety
The study was stopped early (reason given: Challenging enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Ashraf S Habib, MD principal investigator
Duke University
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 Pre-Eclampsia and Neurocognitive Dysfunction, run by Duke University 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 9 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: stopped early, as of the sponsor's last update on 29 Jun 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 was stopped early (reason given: Challenging enrollment). Results are not available in the source record.
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?
Number of white matter lesions (time frame: Postpartum (2-6 weeks or while hospitalized)). The study lists 3 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 29 Jun 2022.