Hepatitis B Virus Infection; Pregnant WomenNCT02391467
Validity of Elastography During Pregnancy
An observational study of Hepatitis B Virus Infection; Pregnant Women, run by Hopital Lariboisière at 1 site in France.
Trial summary
Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hepatitis B Virus Infection; Pregnant Women
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2015
- How long will I take part?
- 6 Months
- 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: Pregnant women with HBV or HCV chronic hepatitis
Who may be able to join
- Pregnant women
- Followed in Obstetrics Dpt
- HBV or HCV chronic hepatitis
- After information and written consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study
Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.
Read the detailed description
One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the fibrosis score during and after pregnancy
Measured: 3 to 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: issue concerning safety of elastography during pregnancy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus Infection; Pregnant WomenStudies 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
- 25 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Mouly, MD PhD, Hopital Lariboisière
- Investigators
- Pierre O SELLIER, MD, PhD, Principal investigator, Hopital Lariboisiere, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391467
- Sponsor's protocol ID
- Liver006
- Status last verified
- Sep 2015
- First submitted
- 12 Mar 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study
- ClinicalTrials.gov ID
- NCT02391467
- Acronym / sponsor ID
- Liver006
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: issue concerning safety of elastography during pregnancy
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Mar 2015 (estimated)
- 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.
Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.
Detailed description
One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with HBV or HCV chronic hepatitis
Key inclusion criteria (4 listed)
- Pregnant women
- Followed in Obstetrics Dpt
- HBV or HCV chronic hepatitis
- After information and written consent
Key exclusion criteria (1 listed)
- None
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
Difference between the fibrosis score during and after pregnancy
Time frame: 3 to 6 months after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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.
Pierre O SELLIER, MD, PhD principal investigator
Hopital Lariboisiere, Paris, France
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 Hepatitis B Virus Infection; Pregnant Women, run by Hopital Lariboisière at 1 site in France.
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 4 inclusion and 1 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: paused, as of the sponsor's last update on 2 Oct 2015. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the fibrosis score during and after pregnancy (time frame: 3 to 6 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2015.