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Challenging enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Eclampsia | 15 English-speaking women with severe pre-eclampsia |
| |
| Control | 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuroimaging Procedures | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of white matter lesions | DTI white matter patency in women with pre-eclampsia/eclampsia. | Postpartum (2-6 weeks or while hospitalized) |
| Classification of white matter lesions | Classify the nature of co-morbid DTI white matter patency/lesions | Postpartum (2-6 weeks or while hospitalized) |
| Neurocognitive Function Scores | Scores from the neurocognitive testing combined to give overall score for function. | Up to 1 day before delivery |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf S Habib, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Neuropsychological Assessment Procedures | Diagnostic 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 |
|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |