Status:
COMPLETED
Multicentric Prospective Study to Screen Inborn Errors of Metabolism in Non-immune Hydrops (NIH) Fetalis by Massively Parallel Sequencing
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Non-Immune Hydrops Fetalis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
A fetal hydrops, also called a fetal anasarca, is the buildup of fluid in the serosa and / or fetal subcutaneous tissue. The diagnosis is made by ultrasound, possibly from the first trimester of pregn...
Eligibility Criteria
Inclusion
- patient\> 18 years old
- Single Pregnancy
- Progressive pregnancy greater than 11 weeks: Fetal death in utero in a fetus previously known to be a carrier of non Immun Hydrops (NIH) is not an exclusion criterion.
- Presence of an ultrasound defined as follows and confirmed by a multidisciplinary prenatal diagnostic center CPDPN:
- Before 14 weeks: Generalized subcutaneous edema descending to the abdomen, associated or not with peri-visceral effusion
- After 14 weeks: presence of at least 2 of the following criteria: ascites, pleural effusion, pericardial effusion, subcutaneous edema, placental edema, hydramnios.
- Persistent hygroma after 14 weeks of amenorrhea
- Persistent isolated perivisceral effusions without etiologies found
- Patient having an invasive diagnostic sample (amniocentesis)
- Social insured in France
- Patient who signed the informed consent of the study
Exclusion
- NIH whose diagnosis is known and confirmed as non-metabolic by a CPDPN
- Non-progressive pregnancy with Fetal Death in utero with normal previous ultrasound monitoring
- Refusal of invasive diagnostic sampling
- Patient under legal protection measure
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04308603
Start Date
April 12 2021
End Date
April 12 2024
Last Update
November 8 2024
Active Locations (17)
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1
CHU Besançon
Besançon, France, 25000 Besancon
2
CHU Pellegrin
Bordeaux, France, 33076
3
Hôpital Femme Mère Enfant
Bron, France, 69500
4
Hôpital d'Estaing
Clermont-Ferrand, France, 63003