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Pregnancy and Fibrinogen Disorders (FIBRINOGEST)

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ClinicalTrials.gov Identifier: NCT03920332
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Swiss Hemophilia Network
Information provided by (Responsible Party):
Casini Alessandro, University Hospital, Geneva

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Hypofibrinogenemia, Congenital Afibrinogenemia, Congenital Dysfibrinogenemia, Congenital

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
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of normal issue pregnancy [ Time Frame: At inclusion ]
    All pregnancy not resulting in miscarriage, stillbirth or abortion


Secondary Outcome Measures :
  1. Prevalence of pregnancy without complications [ Time Frame: At inclusion ]
    All pregnancy not resulting in intrauterine growth retardation, preterm labor, pregnancy-induced hypertension, gestational diabetes, preeclampsia, abruption placenta, anamniota, vaginal bleeding requiring medical intervention

  2. Modalities of delivery [ Time Frame: At inclusion ]
    Vaginal versus caesarean cut

  3. Modalities of delivery [ Time Frame: At inclusion ]
    Instrumental delivery vs none

  4. Post-partum complications [ Time Frame: At inclusion ]
    Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery

  5. Fibrinogen variations [ Time Frame: At inclusion ]
    Fibrinogen levels throughout the pregnancy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women will be recruited in Hemophilia Centers.
Criteria

Inclusion Criteria:

  • Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
  • At lest one past pregnancy
  • Adult

Exclusion Criteria:

  • No past pregnancy
  • Not confirmed fibrinogen disorder
Contacts and Locations
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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): NCT03920332


Contacts
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Contact: Alessandro Casini, MD +41223729757 alessandro.casini@hcuge.ch

Locations
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France
Hopital Port-Royal Not yet recruiting
Paris, France, 75014
Contact: Justine Hugon-Rodin, MD, PHD    +33158413550    justine.hugon-rodin@aphp.fr   
Slovakia
Jessenius Faculty of Medicine and University Hospital Recruiting
Martin, Slovakia, 03659
Contact: Tomas Simurda, MD PHD    +421434203232    tomas.simurda@uniba.sk   
Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland
Contact: Alessandro Casini, MD    +41223729757    alessandro.casini@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Swiss Hemophilia Network
Investigators
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Principal Investigator: Alessandro Casini, MD University Hospitals of Geneva
Principal Investigator: Justine Hugon-Rodin, MD, PHD APHP
More Information
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Responsible Party: Casini Alessandro, MD, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03920332    
Other Study ID Numbers: CCER2019-00353
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Casini Alessandro, University Hospital, Geneva:
Pregnancy
obstetric
miscarriage
haemorrhage
fibrinogen
Additional relevant MeSH terms:
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Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn