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Clinical Trials/NCT03920332
NCT03920332
Completed
Not Applicable

Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

University Hospital, Geneva3 sites in 3 countries149 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypofibrinogenemia, Congenital
Sponsor
University Hospital, Geneva
Enrollment
149
Locations
3
Primary Endpoint
Prevalence of normal issue pregnancy
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Casini Alessandro

MD, Principal Investigator

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • No past pregnancy
  • Not confirmed fibrinogen disorder

Outcomes

Primary Outcomes

Prevalence of normal issue pregnancy

Time Frame: At inclusion

All pregnancy not resulting in miscarriage, stillbirth or abortion

Secondary Outcomes

  • Prevalence of pregnancy without complications(At inclusion)
  • Post-partum complications(At inclusion)
  • Modalities of delivery(At inclusion)
  • Fibrinogen variations(At inclusion)

Study Sites (3)

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