Status:
RECRUITING
Study of Placental Vascularization Using Contrast Ultrasound
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Fetal Growth Restriction
Eligibility:
FEMALE
18-64 years
Phase:
PHASE3
Brief Summary
Preeclampsia and intrauterine growth restriction (IUGR) are two principal complications of pregnancy. These diseases are related to placental dysfunction nevertheless knowledge of its pathophysiologic...
Detailed Description
The primary objective is 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06497959
Start Date
April 9 2025
End Date
April 10 2029
Last Update
May 31 2025
Active Locations (1)
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1
CHRU de NANCY
Nancy, France, 54000