Pregnancy and Fibrinogen Disorders

Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03920332

Acronym

FIBRINOGEST

Enrollment

149

Registered

2019-04-18

Start date

2019-09-01

Completion date

2022-05-01

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Afibrinogenemia, Congenital, Dysfibrinogenemia, Congenital, Hypofibrinogenemia, Congenital

Keywords

Pregnancy, obstetric, miscarriage, haemorrhage, fibrinogen

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No past pregnancy * Not confirmed fibrinogen disorder

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of normal issue pregnancy	At inclusion	All pregnancy not resulting in miscarriage, stillbirth or abortion

Secondary

Measure	Time frame	Description
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
Modalities of delivery	At inclusion	Vaginal versus caesarean cut
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

Countries

France, Slovakia, Switzerland

Outcome results