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Contribution of Contrast-Enhanced Ultrasound (CES) in the fetal-placental circulation study: EVUPACUS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506936-34-00
Acronym
2021PI062
Enrollment
30
Registered
2024-05-17
Start date
2025-04-09
Completion date
Unknown
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal growth restriction

Brief summary

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.

Detailed description

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., 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)., Objective 4: Obtaining placental samples to study the deposition of sulphur hexafluoride in the placenta using electronic microscopy.

Interventions

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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., 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)., Objective 4: Obtaining placental samples to study the deposition of sulphur hexafluoride in the placenta using electronic microscopy.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026