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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03863639
Enrollment
18
Registered
2019-03-05
Start date
2014-07-07
Completion date
2022-04-13
Last updated
2022-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Dysfunction, Pre-Eclampsia

Keywords

Pre-Eclampsia, Functional Magnetic Resonance Imaging, Neurocognitive Function

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.

Interventions

DIAGNOSTIC_TESTNeuroimaging Procedures

Subjects will complete neuroimaging procedures at 2-6-week postpartum or during hospitalization after delivery prior to discharge, which will consist of high-resolution anatomic, perfusion and resting-brain fMRI sequences; all of which will be acquired on a 3-Tesla General Electric magnetic resonance scanner provided by the Brain Imaging and Analysis Center (BIAC) at Duke University. No contrast agent will be administered in these imaging procedures.

DIAGNOSTIC_TESTNeuropsychological Assessment Procedures

Once identified as meeting study criteria and consented for participation, parturients will be tested during hospitalization or as outpatients for controls, and at 2-6 weeks postpartum with the following cognitive battery. Wechsler Test of Adult Reading (WTAR), CANTABeclipse Computerized Cognitive Assessment Measures, Stroop Color-Word Test, Controlled Oral Word Association Test, EuroQol, Beck Depression Inventory Revised

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of white matter lesionsPostpartum (2-6 weeks or while hospitalized)DTI white matter patency in women with pre-eclampsia/eclampsia.
Classification of white matter lesionsPostpartum (2-6 weeks or while hospitalized)Classify the nature of co-morbid DTI white matter patency/lesions
Neurocognitive Function ScoresUp to 1 day before deliveryScores from the neurocognitive testing combined to give overall score for function.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026