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

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ClinicalTrials.gov Identifier: NCT03299777
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Western Galilee Hospital-Nahariya

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


Condition or disease
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
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299777


Contacts
Contact: Maya Wolf, MD 972-507887800 mayaf@gmc.gov.il
Contact: Maya Wolf, MD 972-507887800 HOMESICKID@YAHOO.COM

Locations
Israel
Galil Medical Center Recruiting
Nahariya, Israel
Contact: Maya Wolf, MD    972-507887800    homesickid@yahoo.com   
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Maya Wolf, MD Western Galilee Medical Center

Responsible Party: Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT03299777     History of Changes
Other Study ID Numbers: 0036-17-NHR
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications