Clinical trial NCT03299777: Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
Official title: Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2017-10-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor.

Materials and Methods

Detailed description: The purpose of the study is to compare the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor.

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.

Eligibility criteria: Inclusion Criteria:

- Fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia

Exclusion Criteria:

* Age less then 18
* Fetal-maternal less then 24 weeks

Primary outcomes:
measure: Comparing the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. Fibrotic tissue differs from healthy tissue in the way it responds to excitation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galil Medical Center
Study officials:
affiliation: Western Galilee Medical Center
name: Maya Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.