SULFUR HEXAFLUORIDE for Fetal growth restriction

Inclusion criteria

• {"criterion_text":"- Adult woman (age ≥18 years)"}
• {"criterion_text":"- Gestational age between 16 GW + 0 days and GW + 6 days"}
• {"criterion_text":"- Singleton pregnancy"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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

• {"criterion_text":"- Any medical condition contraindicating the administration of SonoVue, in particular: •\tHypersensitivity to sulphur hexafluoride or to one of the other components of SonoVue® such as polyethylene glycol (PEG), •\tWomen with recent acute coronary syndrome or unstable ischaemic heart disease, •\tWomen 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."}
• {"criterion_text":"- Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code: •\tBreast-feeding mother •\tMinor (not emancipated) •\tAn adult subject to a legal protection (guardianship, curatorship, safeguard of justice) •\tAn adult unable to give consent"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Person who do not speak French"}

Primary endpoints

• {"endpoint_text":"- Comparison of placental contrast ultrasound parameters according to the group defined by fetal weight in percentile as a function of term. Severe IntraUterine Growth Restriction (IUGR) is defined as a weight below the 3rd percentile for gestational age.","definition_or_measurement_approach":"Comparison of placental contrast ultrasound parameters between groups defined by fetal weight percentile; severe IUGR defined as weight <3rd percentile for gestational age. Measurement via contrast-enhanced ultrasound (ECUS) parameters."}

Secondary endpoints

• {"endpoint_text":"- Objectives 1 and 2: Measurement of the perfusion kinetics of the contrast agent in ECUS on the foetal side (parameters of the semi-quantitative analysis obtained using VueBox software) for all patients, if applicable. In case no contrast medium passes through the cord, perfusion kinetics will not be measured.","definition_or_measurement_approach":"Semi-quantitative analysis of perfusion kinetics on the fetal side using VueBox software; measurements will be omitted if no contrast passes through the cord."}
• {"endpoint_text":"- Objective 3: Association between ECUS vascularisation parameters and placental histology data (macro- and microscopic indices based on Amsterdam Standardised Analysis Criteria): placental weight, cord length, presence of macroscopic lesions (infarction, thrombosis, fibrin, calcification, haematoma), presence of histological lesions of maternal placental with bad perfusion (distal villous hypoplasia, infarction, decidual vasculopathy).","definition_or_measurement_approach":"Correlation analyses between ECUS vascularisation parameters and standardized placental histology indices (Amsterdam criteria) including macroscopic and microscopic lesions and metrics (placental weight, cord length, lesion presence)."}
• {"endpoint_text":"- Objective 4: Obtaining placental samples to study the deposition of sulphur hexafluoride in the placenta using electronic microscopy.","definition_or_measurement_approach":"Collection of placental samples with subsequent electron microscopy to assess deposition of sulphur hexafluoride."}

France

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

17-05-2024

Processing Time Days

32

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France