Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT04308603
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04308603
Study Brief:
Protocol Section:
NCT04308603