Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
1 other identifier
observational
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2017
CompletedFirst Submitted
Initial submission to the registry
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedOctober 24, 2017
October 1, 2017
2.1 years
September 25, 2017
October 23, 2017
Conditions
Outcome Measures
Primary Outcomes (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
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
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- \- Fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia
You may not qualify if:
- Age less then 18
- Fetal-maternal less then 24 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Galil Medical Center
Nahariya, Israel
Related Publications (1)
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.
PMID: 35500613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maya Wolf, MD
Western Galilee Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2017
First Posted
October 3, 2017
Study Start
September 5, 2017
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
October 24, 2017
Record last verified: 2017-10