CTIS2023-506936-34-00
Active, Not Recruiting
Phase 1
Contribution of Contrast-Enhanced Ultrasound (CES) in the fetal-placental circulation study: EVUPACUS - 2021PI062
CHRU De Nancy0 sites30 target enrollmentFebruary 20, 2024
ConditionsFetal growth restrictionMedDRA version: 20.0Level: PTClassification code: 10070531Term: Foetal growth restriction Class: 100000004868Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fetal growth restriction
- Sponsor
- CHRU De Nancy
- Enrollment
- 30
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult woman (age \=18 years), Gestational age between 16 GW \+ 0 days and GW \+ 6 days, Singleton pregnancy, Whose request of a medical termination of pregnancy (IMG) has been formulated and accepted in a written form by the Centre Pluridisciplinaire de Diagnostic Prénatal (CPDPN) of the CHRU de Nancy, Criteria specific to patients in the growth restriction group: \- Severe growth restriction defined by an estimation of foetal weight below the 3rd percentile using ultrasound performed no more than 15 days prior to the IMG (the diagnosis must be established at the time of the request for IMG in routine care).
Exclusion Criteria
- •Any medical condition contraindicating the administration of SonoVue, in particular: •Hypersensitivity to sulphur hexafluoride or to one of the other components of SonoVue® such as polyethylene glycol (PEG), •Women with recent acute coronary syndrome or unstable ischaemic heart disease, •Women with a right\-to\-left shunt, severe pulmonary arterial hypertension (pulmonary arterial pressure \> 90 mmHg), uncontrolled systemic hypertension and women suffering from respiratory distress syndrome., Persons covered by articles L. 1121\-5, L. 1121\-7 and L1121\-8 of the French Public Health Code: •Breast\-feeding mother •Minor (not emancipated) •An adult subject to a legal protection (guardianship, curatorship, safeguard of justice) •An adult unable to give consent, Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles L. 3212\-1 and L. 3213\-1, Person who do not speak French
Outcomes
Primary Outcomes
Not specified
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