NCT03920332

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

April 12, 2019

Last Update Submit

November 1, 2022

Conditions

Hypofibrinogenemia, CongenitalAfibrinogenemia, CongenitalDysfibrinogenemia, Congenital

Keywords

Pregnancyobstetricmiscarriagehaemorrhagefibrinogen

Outcome Measures

Primary Outcomes (1)

  • Prevalence of normal issue pregnancy

    All pregnancy not resulting in miscarriage, stillbirth or abortion

    At inclusion

Secondary Outcomes (5)

  • Prevalence of pregnancy without complications

    At inclusion

  • Modalities of delivery

    At inclusion

  • Modalities of delivery

    At inclusion

  • Post-partum complications

    At inclusion

  • Fibrinogen variations

    At inclusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women will be recruited in Hemophilia Centers.

You may qualify if:

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

You may not qualify if:

  • No past pregnancy
  • Not confirmed fibrinogen disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Port-Royal

Paris, 75014, France

Location

Jessenius Faculty of Medicine and University Hospital

Martin, 03659, Slovakia

Location

University Hospitals of Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

AfibrinogenemiaDysfibrinogenemia, CongenitalAbortion, SpontaneousHemorrhage

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alessandro Casini, MD

    University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

  • Justine Hugon-Rodin, MD, PHD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 18, 2019

Study Start

September 1, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)SL(1)FR(1)