Pregnancy and Fibrinogen Disorders (FIBRINOGEST)

November 1, 2022 updated by: Casini Alessandro, University Hospital, Geneva

Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Port-Royal
  • Slovakia
      • Martin, Slovakia, 03659
        • Jessenius Faculty of Medicine and University Hospital
  • Switzerland
      • Geneva, Switzerland
        • University Hospitals of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women will be recruited in Hemophilia Centers.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No past pregnancy
  • Not confirmed fibrinogen disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of pregnancy without complications
Time Frame: 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
At inclusion
Modalities of delivery
Time Frame: At inclusion
Vaginal versus caesarean cut
At inclusion
Modalities of delivery
Time Frame: At inclusion
Instrumental delivery vs none
At inclusion
Post-partum complications
Time Frame: At inclusion
Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery
At inclusion
Fibrinogen variations
Time Frame: At inclusion
Fibrinogen levels throughout the pregnancy
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Swiss Hemophilia Network

Investigators

  • Principal Investigator: Justine Hugon-Rodin, MD, PHD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCER2019-00353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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