Study of placental vascularization using contrast ultrasound

Phase 1

• Conditions: Fetal growth restriction; MedDRA version: 20.0Level: PTClassification code: 10070531Term: Foetal growth restriction Class: 100000004868; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: CTIS2023-506936-34-00
• Lead Sponsor: CHRU De Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare placental contrast ultrasound in patients with medical termination of pregnancy at gestational age 16 weeks – (38 weeks+ 6 days) between two groups: the fetal growth restriction one and the no fetal growth restriction;Secondary Objective: To describe the placental vascularisation parameters measured by ECUS for all patients., To describe the parameters for quantifying vascularisation at different gestational ages using ECUS., To study the associations between ECUS data and placental histological data., To establish a biological collection of placentas in order to study consequences of the use of sulphur hexafluoride in the placenta.;Primary end point(s): 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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):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.;Secondary end point(s):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).;Secondary end point(s):Objective 4: Obtaining placental samples to study the deposition of sulphur hexafluoride in the placenta using electronic microscopy.