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Clinical Trials/CTIS2023-506936-34-00
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

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.

Registry
who.int
Start Date
February 20, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
CHRU De Nancy

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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