Pregnancy and Fibrinogen Disorders

Afibrinogenemia, Congenital Clinical Trial

— FIBRINOGEST  

Official title:

Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920332
• Other study ID #: CCER2019-00353
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No past pregnancy
• Not confirmed fibrinogen disorder

Related Conditions & MeSH terms

• Afibrinogenemia
• Afibrinogenemia, Congenital
• Dysfibrinogenemia, Congenital
• Hypofibrinogenemia, Congenital

Locations

Country	Name	City	State
France	Hopital Port-Royal	Paris
Slovakia	Jessenius Faculty of Medicine and University Hospital	Martin
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss Hemophilia Network

Countries where clinical trial is conducted

France,  Slovakia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of normal issue pregnancy	All pregnancy not resulting in miscarriage, stillbirth or abortion	At inclusion
Secondary	Prevalence of pregnancy without complications	All pregnancy not resulting in intrauterine growth retardation, preterm labor, pregnancy-induced hypertension, gestational diabetes, preeclampsia, abruption placenta, anamniota, vaginal bleeding requiring medical intervention	At inclusion
Secondary	Modalities of delivery	Vaginal versus caesarean cut	At inclusion
Secondary	Modalities of delivery	Instrumental delivery vs none	At inclusion
Secondary	Post-partum complications	Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery	At inclusion
Secondary	Fibrinogen variations	Fibrinogen levels throughout the pregnancy	At inclusion