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Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia

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ClinicalTrials.gov Identifier: NCT03863639
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date March 4, 2019
First Posted Date March 5, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date July 7, 2014
Estimated Primary Completion Date February 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: March 4, 2019)
  • 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
Change History Complete list of historical versions of study NCT03863639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia
Official Title A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition
  • Pre-Eclampsia
  • Neurocognitive Dysfunction
Intervention
  • Diagnostic Test: Neuroimaging Procedures

    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.

  • Diagnostic Test: Neuropsychological Assessment Procedures
    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 Groups/Cohorts
  • Pre-Eclampsia
    15 English-speaking women with severe pre-eclampsia
    Interventions:
    • Diagnostic Test: Neuroimaging Procedures
    • Diagnostic Test: Neuropsychological Assessment Procedures
  • Control
    15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age
    Interventions:
    • Diagnostic Test: Neuroimaging Procedures
    • Diagnostic Test: Neuropsychological Assessment Procedures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 4, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 7, 2020
Estimated Primary Completion Date February 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:Severe Pre-Eclampsia defined by

  • 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)
  • 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.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ashraf S Habib, MD 9196814544 ashraf.habib@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03863639
Other Study ID Numbers Pro00055293
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Ashraf S Habib, MD Duke University
PRS Account Duke University
Verification Date March 2019