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

Duke University

Status

Terminated

Conditions

Pre-Eclampsia

Neurocognitive Dysfunction

Treatments

Diagnostic Test: Neuropsychological Assessment Procedures

Diagnostic Test: Neuroimaging Procedures

Study type

Observational

Funder types

Other

Identifiers

NCT03863639

Pro00055293

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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