Study of Placental Vascularization Using Contrast Ultrasound

NCT06497959 · tracked via the Priya Life Science France tracker

Sponsor

Central Hospital, Nancy, France

Phase

Phase 3

Started

2025-04-09

Last updated

2026-04-07

Condition(s) studied

Fetal Growth Restriction

Investigational drug(s) / intervention(s)

SonoVue →

SonoVue: Placental contrast ultrasound using SonoVue by maternal intravenous injection

Study summary

Preeclampsia and intrauterine growth restriction (IUGR) are two principal complications of pregnancy. These diseases are related to placental dysfunction nevertheless knowledge of its pathophysiological mechanisms remains inadequate.

No etiological treatment for these pathologies is available. Inducing birth is the only way to prevent the occurrence of these complications (such as fetal death in utero.

Therefore, a better understanding of placental vascularization under pathological and physiological conditions is necessary. This placental vascularization evolves throughout gestation. Histological studies have improved our knowledge of placental vascular pathologies; however, these are ex vivo data that only provide an incomplete reflection of placental function. In vivo placental studies are therefore essential to understand the mechanisms of placental perfusion. Currently, these studies are limited because the available tools (such as placental Doppler) do not allow for the separate study of maternal placental flow from fetal flow. However, histological evidence clearly establishes maternal placental vascular involvement in IUGR. It would therefore be interesting to study maternal and fetal placental vascularization separately. The development of new in vivo imaging exploration techniques will help to better understand placental pathologies.

In obstetrics, CES would offer the opportunity to study in vivo placental vascularization in a segmented manner (maternal versus fetal side independently) since the microbubbles do not cross the placental barrier. Animal studies show no toxic effects on fetal development nor any crossing of the placental barrier. In humans, the innovative use of this contrast agent has allowed for a better understanding of placental vascularization in the first trimester of pregnancy.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

64 Years

Healthy volunteers

Inclusion Criteria: * Adult woman (age ≥18 years), * Gestational age between 16 GW + 0 days and 38 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 Centre Hospitalier Régional Universaitaire (CHRU) de Nancy, * Affiliated to the social security system or benefit from such a system, * Having received full information and having signed an informed consent form. 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: * Person who do not speak French * Any medical condition contraindicating the administration of SonoVue, in particular: * Hypersensitivity to sulfur 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

Primary outcome measure(s)

The measurement of signal strength — 1 day
The measurement of signal strength (in arbitrary units) in the Inter-Villi Space of the placetna ,obtained by contrast ultrasound, in women who have confirmed a medical termination of pregnancy 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.For each group, these parameters will be obtained by qualitative analysis (i.e. presence/absence of contrast medium passage) and semi-quantitative analysis (enhancement percentage, area under the curve, time to peak, slopes -wash-in rate and wash-out rate, etc.) using dedicated software VueBox, BRACCO

Trial sites (1)

Facility	City	Region	Status
CHRU de NANCY	Nancy	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06497959 on ClinicalTrials.gov ↗ ← All trials in France