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Pregnancy and Fibrinogen Disorders (FIBRINOGEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03920332
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : September 29, 2021
Swiss Hemophilia Network
Information provided by (Responsible Party):
Casini Alessandro, University Hospital, Geneva

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.

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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 : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Fibrinogen

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

Inclusion Criteria:

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

Exclusion Criteria:

  • No past pregnancy
  • Not confirmed fibrinogen disorder

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 identifier (NCT number): NCT03920332

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Contact: Alessandro Casini, MD +41223729757

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Hopital Port-Royal Not yet recruiting
Paris, France, 75014
Contact: Justine Hugon-Rodin, MD, PHD    +33158413550   
Jessenius Faculty of Medicine and University Hospital Recruiting
Martin, Slovakia, 03659
Contact: Tomas Simurda, MD PHD    +421434203232   
University Hospitals of Geneva Recruiting
Geneva, Switzerland
Contact: Alessandro Casini, MD    +41223729757   
Sponsors and Collaborators
University Hospital, Geneva
Swiss Hemophilia Network
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Principal Investigator: Alessandro Casini, MD University Hospitals of Geneva
Principal Investigator: Justine Hugon-Rodin, MD, PHD APHP
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Responsible Party: Casini Alessandro, MD, Principal Investigator, University Hospital, Geneva Identifier: NCT03920332    
Other Study ID Numbers: CCER2019-00353
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
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:
Additional relevant MeSH terms:
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Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn