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出境医 / 临床实验 / Pregnancy and Fibrinogen Disorders (FIBRINOGEST)
Pregnancy and Fibrinogen Disorders (FIBRINOGEST)
Study Description
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.
| Condition or disease |
|---|
| Hypofibrinogenemia, Congenital Afibrinogenemia, Congenital Dysfibrinogenemia, Congenital |
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 Design
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | May 1, 2021 |
| Estimated Study Completion Date : | September 1, 2021 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Prevalence of normal issue pregnancy [ Time Frame: At inclusion ]All pregnancy not resulting in miscarriage, stillbirth or abortion
Secondary Outcome Measures :
- 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
- Modalities of delivery [ Time Frame: At inclusion ]Vaginal versus caesarean cut
- Modalities of delivery [ Time Frame: At inclusion ]Instrumental delivery vs none
- Post-partum complications [ Time Frame: At inclusion ]Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery
- Fibrinogen variations [ Time Frame: At inclusion ]Fibrinogen levels throughout the pregnancy
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Women will be recruited in Hemophilia Centers.
Criteria
Inclusion Criteria:
- Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
- At lest one past pregnancy
- Adult
Exclusion Criteria:
- No past pregnancy
- Not confirmed fibrinogen disorder
Contacts and Locations
Contacts
| Contact: Alessandro Casini, MD | +41223729757 | alessandro.casini@hcuge.ch |
Locations
| France | |
| Hopital Port-Royal | Not yet recruiting |
| Paris, France, 75014 | |
| Contact: Justine Hugon-Rodin, MD, PHD +33158413550 justine.hugon-rodin@aphp.fr | |
| Slovakia | |
| Jessenius Faculty of Medicine and University Hospital | Recruiting |
| Martin, Slovakia, 03659 | |
| Contact: Tomas Simurda, MD PHD +421434203232 tomas.simurda@uniba.sk | |
| Switzerland | |
| University Hospitals of Geneva | Recruiting |
| Geneva, Switzerland | |
| Contact: Alessandro Casini, MD +41223729757 alessandro.casini@hcuge.ch | |
Sponsors and Collaborators
University Hospital, Geneva
Swiss Hemophilia Network
Investigators
| Principal Investigator: | Alessandro Casini, MD | University Hospitals of Geneva | |
| Principal Investigator: | Justine Hugon-Rodin, MD, PHD | APHP |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | April 12, 2019 | ||||||
| First Posted Date | April 18, 2019 | ||||||
| Last Update Posted Date | April 28, 2021 | ||||||
| Actual Study Start Date | September 1, 2019 | ||||||
| Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Prevalence of normal issue pregnancy [ Time Frame: At inclusion ] All pregnancy not resulting in miscarriage, stillbirth or abortion
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Pregnancy and Fibrinogen Disorders | ||||||
| Official Title | Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders | ||||||
| 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 Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Women will be recruited in Hemophilia Centers. | ||||||
| Condition |
|
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| Intervention | Not Provided | ||||||
| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
200 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | September 1, 2021 | ||||||
| Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | France, Slovakia, Switzerland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03920332 | ||||||
| Other Study ID Numbers | CCER2019-00353 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Casini Alessandro, University Hospital, Geneva | ||||||
| Study Sponsor | University Hospital, Geneva | ||||||
| Collaborators | Swiss Hemophilia Network | ||||||
| Investigators |
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| PRS Account | University Hospital, Geneva | ||||||
| Verification Date | April 2021 | ||||||
