Study of Placental Vascularization Using Contrast Ultrasound

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Jul 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how blood flows in the placenta during pregnancy, especially in cases of fetal growth restriction, a condition where a baby does not grow as expected in the womb. Researchers want to learn more about how the placenta works in both healthy pregnancies and those affected by complications like preeclampsia. By using a special ultrasound technique with contrast agents, they can visualize the blood flow from both the mother and the fetus separately, which is important for understanding and diagnosing these conditions more accurately.

To participate in this trial, women must be at least 18 years old and have a singleton pregnancy (meaning just one baby) between 16 and 38 weeks of gestation. They must also have been recommended for a medical termination of pregnancy due to severe growth restriction of the fetus. Participants will receive detailed information about the study, and they will need to sign a consent form to take part. The trial is currently recruiting, and the ultrasound procedures used have shown no harmful effects on fetal development in previous studies.

Gender

FEMALE

Eligibility criteria

• 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