Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan

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

Materials and Methods

Study Overview

• Status: Unknown
• Conditions: Pre-Eclampsia

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel
    • Recruiting
    • Galil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
Preeclampsia group; All patients diagnosed with preeclampsia will undergo the fibroscan test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Transient elastography is performed using transducer-induced vibrations at low frequency (50 Hz) and amplitudes. The transmitted shear waves propagate through the liver parenchyma. Pulse-echo ultrasound acquisition is used to follow the propagation of the shear wave and to measure its average speed. Results are expressed in kPa and can range from 2.5 to 75 kPa. Commonly used cutoffs in clinical settings are >7 kPa for significant fibrosis and >11 to 14 kPa for cirrhosis and CAP>270 db/m2 for significant steatosis.	2 years

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Maya Wolf, MD, Western Galilee Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 1, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 0036-17-NHR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No