Pregnancy and Fibrinogen Disorders

Completed

• Conditions: Hypofibrinogenemia, Congenital; Afibrinogenemia, Congenital; Dysfibrinogenemia, Congenital

• Registration Number: NCT03920332
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Study Start: 2019-09-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

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

Exclusion Criteria

• No past pregnancy
• Not confirmed fibrinogen disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of normal issue pregnancy	At inclusion	All pregnancy not resulting in miscarriage, stillbirth or abortion

Secondary Outcome Measures

Name	Time	Method
Modalities of delivery	At inclusion	Instrumental delivery vs none
Prevalence of pregnancy without complications	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
Post-partum complications	At inclusion	Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery
Fibrinogen variations	At inclusion	Fibrinogen levels throughout the pregnancy

Trial Locations

Locations (3)

Hopital Port-Royal; 🇫🇷 Paris, France

Jessenius Faculty of Medicine and University Hospital; 🇸🇰 Martin, Slovakia

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland