Status:
TERMINATED
Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia
Lead Sponsor:
Duke University
Conditions:
Pre-Eclampsia
Neurocognitive Dysfunction
Eligibility:
FEMALE
18-45 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03863639
Start Date
July 7 2014
End Date
April 13 2022
Last Update
June 29 2022
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710