Pre-EclampsiaNCT03299777
Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
An observational study of Pre-Eclampsia, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Sep 2017to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia
Who cannot join
- Age less then 18
- Fetal-maternal less then 24 weeks
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Galil Medical Center
Nahariya
Maya Wolf, MD, 972-507887800, homesickid@yahoo.com
About this study
Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor.
Materials and Methods
Read the 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.
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start5 Sep 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maya Wolf, MD, Principal investigator, Western Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299777
- Sponsor's protocol ID
- 0036-17-NHR
- Status last verified
- Oct 2017
- First submitted
- 25 Sep 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35500613
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
- ClinicalTrials.gov ID
- NCT03299777
- Acronym / sponsor ID
- 0036-17-NHR
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia
Key exclusion criteria (2 listed)
- Age less then 18
- Fetal-maternal less then 24 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Derived from this study: PubMed 35500613Carmiel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Wolf, MD principal investigator
Western Galilee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Wolf, MD (972-507887800, mayaf@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.