A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Duke University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Classification of white matter lesions
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Number of white matter lesions
Time Frame: Postpartum (2-6 weeks or while hospitalized)
DTI white matter patency in women with pre-eclampsia/eclampsia.
Neurocognitive Function Scores
Time Frame: Up to 1 day before delivery
Scores from the neurocognitive testing combined to give overall score for function.
Secondary Outcomes
No secondary outcomes reported