Clinical trial NCT03863639: Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia
Official title: A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pre-Eclampsia
Neurocognitive Dysfunction
Keywords: Pre-Eclampsia
Functional Magnetic Resonance Imaging
Neurocognitive Function
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients with severe pre-eclampsia on the labor and delivery ward and healthy controls presenting to the antenatal clinic or the labor ward will be screened. 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.

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.


Eligibility 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

Primary outcomes:
measure: Number of white matter lesions
timeFrame: Postpartum (2-6 weeks or while hospitalized)
measure: Classification of white matter lesions
timeFrame: Postpartum (2-6 weeks or while hospitalized)
measure: Neurocognitive Function Scores
timeFrame: Up to 1 day before delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashraf S Habib, MD
role: PRINCIPAL_INVESTIGATOR
References: