Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-04-13 @ 9:33 PM
Study NCT ID:
NCT03920332
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy and Fibrinogen Disorders
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBRINOGEST
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: