Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
NCT ID: NCT03299777
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2017-09-05
2019-09-30
Brief Summary
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Materials and Methods
Detailed Description
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Materials and Methods This prospective observational case-control study will include 50 women admitted to the fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia. Preeclampsia is diagnosed as a new onset of hypertension over 140/90, at least two measurements at least four hours apart, and proteinuria (≥+1 in dipstick or \>300 mg/24 hr) after 20 weeks of gestation in a previously normotensive woman.
A control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period. Demographic, clinical, laboratory and sonographic data for the women participating will be collected from their chart. All patients diagnosed with preeclampsia will undergo the following workup: sign and symptoms evaluation, blood pressure follow up, 24-hour protein excretion in grams per day, complete blood count, hepatic function test: AST, ALT and coagulation study, HBA1C, coagulation function test and fibrotest. The Fibroscan test will be performed by a trained hepatologist, who was blind to the women diagnosis. The fibroscan test will be done during the admission after the diagnosis of preeclampsia, after delivery and 6 weeks post-partum.
Commonly used cutoffs are \>7 kPa for significant fibrosis. Statistical analysis will be performed with SPSS using Mann Whitney test. Continuous variables will be analyzed using the student's T test and categorical variables were analyzed using 2. Statistical significance was set at a P value of \< 0.05. The local institutional review board approved this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control group
A control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period
No interventions assigned to this group
Preeclampsia group
All patients diagnosed with preeclampsia will undergo the fibroscan test.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Fetal-maternal less then 24 weeks
18 Years
FEMALE
No
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Principal Investigators
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Maya Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
Western Galilee Medical Center
Locations
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Galil Medical Center
Nahariya, , Israel
Countries
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Central Contacts
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Facility Contacts
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Maya Wolf, MD
Role: primary
References
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Carmiel Haggai M, Sgayer I, Bornstein J, Odeh M, Lowenstein L, Frank Wolf M. Liver stiffness and steatosis in preeclampsia as shown by transient elastography-a prospective cohort study. Am J Obstet Gynecol. 2022 Sep;227(3):515.e1-515.e9. doi: 10.1016/j.ajog.2022.04.048. Epub 2022 Apr 29.
Other Identifiers
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0036-17-NHR
Identifier Type: -
Identifier Source: org_study_id