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Trial record 53 of 56 for:    severe preeclampsia AND weeks of gestation

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

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.

Condition or disease Intervention/treatment
Pre-Eclampsia Neurocognitive Dysfunction Diagnostic Test: Neuroimaging Procedures Diagnostic Test: Neuropsychological Assessment Procedures

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
Actual Study Start Date : July 7, 2014
Estimated Primary Completion Date : February 7, 2020
Estimated Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pre-Eclampsia
15 English-speaking women with severe pre-eclampsia
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

Control
15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age
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




Primary Outcome Measures :
  1. Number of white matter lesions [ Time Frame: Postpartum (2-6 weeks or while hospitalized) ]
    DTI white matter patency in women with pre-eclampsia/eclampsia.

  2. 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

  3. Neurocognitive Function Scores [ Time Frame: Up to 1 day before delivery ]
    Scores from the neurocognitive testing combined to give overall score for function.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863639


Contacts
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Contact: Ashraf S Habib, MD 9196814544 ashraf.habib@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ashraf S Habib, MD    919-681-4544    ashraf.habib@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ashraf S Habib, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03863639     History of Changes
Other Study ID Numbers: Pro00055293
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Pre-Eclampsia
Functional Magnetic Resonance Imaging
Neurocognitive Function
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Cognitive Dysfunction
Hypertension, Pregnancy-Induced
Pregnancy Complications
Cognition Disorders
Neurocognitive Disorders
Mental Disorders