Study of Placental Vascularization Using Contrast Ultrasound
NCT Number: NCT06497959
Acronym: EVUPACUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Fetal Growth Restriction
Interventions: DRUG: SonoVue
Sponsor: Central Hospital, Nancy, France
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-02
Completion Date: 2028-10-01

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.

Primary Outcome Measures: The measurement of signal strength, 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, 1 day
Secondary Outcome Measures: Measurement of the vascularization parameters of the Inter-Villi Space: infusion kinetics., Measurement of the vascularization parameters of the Inter-Villi Space : infusion kinetics by ultrasound with a contrast agent: SonoVue ®., 1 day|Measurement of the vascularization parameters of the umbilical cord: infusion kinetics, Measurement of the vascularization parameters of the umbilical cord: infusion kinetics by ultrasound with a contrast agent: SonoVue ®., 1 day|Measurement of the placenta vascularization using histological analysis, Measurement of the placenta vascularization using histological analysis according to the Amsterdam Standardised Analysis criteria., through study completion, on average of 24 months|Comparison of of the placenta vascularization using histological analysis and the measurement of the vascularization parameters of the Inver-Villi Space., Measurement of the placenta vascularization using histological analysis according to the Amsterdam Standardised Analysis criteria and the vascularization parameters of the umbilical cord: infusion kinetics by ultrasound with a contrast agent: SonoVue ®., through study completion, on average of 24 months