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



Status:Recruiting
Conditions:Cognitive Studies, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:3/15/2019
Start Date:July 7, 2014
End Date:July 7, 2019
Contact:Ashraf S Habib, MD
Email:ashraf.habib@duke.edu
Phone:9196814544

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A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia

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.


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
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-4544
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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