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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299777
• Other study ID #: 0036-17-NHR
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2017
• Last updated: October 23, 2017
• Start date: September 5, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2017
• Source: Western Galilee Hospital-Nahariya
• Contact: Maya Wolf, MD
• Phone: 972-507887800
• Email: mayaf[@]gmc.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
Israel	Galil Medical Center	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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