Hypofibrinogenemia, CongenitalFIBRINOGESTNCT03920332
Pregnancy and Fibrinogen Disorders
An observational study of Hypofibrinogenemia, Congenital and Afibrinogenemia, Congenital, run by University Hospital, Geneva at 3 sites in 3 countries.
Trial summary
The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital, Dysfibrinogenemia, Congenital
- How many people
- 149 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Sep 2019to 1 May 2022
- 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: Women will be recruited in Hemophilia Centers.
Who may be able to join
- Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
- At lest one past pregnancy
- Adult
Who cannot join
- No past pregnancy
- Not confirmed fibrinogen disorder
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Slovakia1 site
Jessenius Faculty of Medicine and University Hospital
Martin, 03659
About this study
Official title: Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders
The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.
Read the detailed description
Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.
- Conditions
- Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital, Dysfibrinogenemia, Congenital
- Keywords
- Pregnancy, obstetric, miscarriage, haemorrhage, fibrinogen
- Medical subject headings
- Afibrinogenemia, Dysfibrinogenemia, Congenital, Abortion, Spontaneous, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of normal issue pregnancy
All pregnancy not resulting in miscarriage, stillbirth or abortion
Measured: At inclusion
Secondary outcomes (5)
Prevalence of pregnancy without complications
All pregnancy not resulting in intrauterine growth retardation, preterm labor, pregnancy-induced hypertension, gestational diabetes, preeclampsia, abruption placenta, anamniota, vaginal bleeding requiring medical intervention
Measured: At inclusion
Modalities of delivery
Vaginal versus caesarean cut
Measured: At inclusion
Modalities of delivery
Instrumental delivery vs none
Measured: At inclusion
Post-partum complications
Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery
Measured: At inclusion
Fibrinogen variations
Fibrinogen levels throughout the pregnancy
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Sep 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypofibrinogenemia, CongenitalStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Hemophilia Network
- Responsible party
- Principal investigator, Casini Alessandro, University Hospital, Geneva
- Investigators
- Alessandro Casini, MD, Principal investigator, University Hospitals of GenevaJustine Hugon-Rodin, MD, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920332
- Sponsor's protocol ID
- CCER2019-00353
- Acronym
- FIBRINOGEST
- Status last verified
- Nov 2022
- First submitted
- 12 Apr 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders
- ClinicalTrials.gov ID
- NCT03920332
- Acronym / sponsor ID
- FIBRINOGEST / CCER2019-00353
- Conditions
- Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital, Dysfibrinogenemia, Congenital
- Keywords
- Pregnancy, obstetric, miscarriage, haemorrhage, fibrinogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss Hemophilia Network
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 18 Apr 2019 (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.
The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.
Detailed description
Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women will be recruited in Hemophilia Centers.
Key inclusion criteria (3 listed)
- Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
- At lest one past pregnancy
- Adult
Key exclusion criteria (2 listed)
- No past pregnancy
- Not confirmed fibrinogen disorder
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
Prevalence of normal issue pregnancy
Time frame: At inclusion
All pregnancy not resulting in miscarriage, stillbirth or abortion
5 secondary outcomes
Prevalence of pregnancy without complications
Time frame: At inclusion
Modalities of delivery
Time frame: At inclusion
Modalities of delivery
Time frame: At inclusion
Post-partum complications
Time frame: At inclusion
Fibrinogen variations
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Alessandro Casini, MD principal investigator
University Hospitals of Geneva
Justine Hugon-Rodin, MD, PHD principal investigator
APHP
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypofibrinogenemia, Congenital and Afibrinogenemia, Congenital, run by University Hospital, Geneva at 3 sites in 3 countries.
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 3 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: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Slovakia, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of normal issue pregnancy (time frame: At inclusion). 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 Nov 2022.