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

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 |
- 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.

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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 |
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))
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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

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
Contact: Ashraf S Habib, MD | 9196814544 | ashraf.habib@duke.edu |
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 |
Principal Investigator: | Ashraf S Habib, MD | Duke University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pre-Eclampsia Functional Magnetic Resonance Imaging Neurocognitive Function |
Eclampsia Pre-Eclampsia Cognitive Dysfunction Hypertension, Pregnancy-Induced |
Pregnancy Complications Cognition Disorders Neurocognitive Disorders Mental Disorders |