Pre-Eclampsia Clinical Trial
Official title:
A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
NCT number | NCT03863639 |
Other study ID # | Pro00055293 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 7, 2014 |
Est. completion date | April 13, 2022 |
Verified date | June 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 18 |
Est. completion date | April 13, 2022 |
Est. primary completion date | April 13, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of white matter lesions | DTI white matter patency in women with pre-eclampsia/eclampsia. | Postpartum (2-6 weeks or while hospitalized) | |
Primary | Classification of white matter lesions | Classify the nature of co-morbid DTI white matter patency/lesions | Postpartum (2-6 weeks or while hospitalized) | |
Primary | 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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