Study of placental vascularization using contrast ultrasound

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHRU De Nancy

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

9 Apr 2025 → ongoing

Decision date (initial)

2024-05-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

CHRU Nancy

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Diagnosis

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 objectives 4

1. To describe the placental vascularisation parameters measured by ECUS for all patients.
2. To describe the parameters for quantifying vascularisation at different gestational ages using ECUS.
3. To study the associations between ECUS data and placental histological data.
4. To establish a biological collection of placentas in order to study consequences of the use of sulphur hexafluoride in the placenta.

Conditions and MedDRA coding

Fetal growth restriction

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult woman (age ≥18 years)
2. Gestational age between 16 GW + 0 days and GW + 6 days
3. Singleton pregnancy
4. 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
5. 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 4

1. 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.
2. 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
3. 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
4. Person who do not speak French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 3

1. 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.
2. 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).
3. Objective 4: Obtaining placental samples to study the deposition of sulphur hexafluoride in the placenta using electronic microscopy.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHRU De Nancy

Sponsor organisation

CHRU De Nancy

Address

Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034

City

Nancy Cedex

Postcode

54035

Country

France

Scientific contact point

Organisation

CHRU De Nancy

Contact name

Matthieu DAP

Public contact point

Organisation

CHRU De Nancy

Contact name

Matthieu DAP

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications