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Pregnancy and Fibrinogen Disorders

NCT ID: NCT03920332

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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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

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Hypofibrinogenemia, Congenital Afibrinogenemia, Congenital Dysfibrinogenemia, Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No past pregnancy
* Not confirmed fibrinogen disorder
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Swiss Hemophilia Network

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Casini Alessandro

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Casini, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva

Justine Hugon-Rodin, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Hopital Port-Royal

Paris, , France

Site Status

Jessenius Faculty of Medicine and University Hospital

Martin, , Slovakia

Site Status

University Hospitals of Geneva

Geneva, , Switzerland

Site Status

Countries

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France Slovakia Switzerland

Other Identifiers

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CCER2019-00353

Identifier Type: -

Identifier Source: org_study_id

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