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New treatment option for Fetal Growth Restriction
Official title Study of Placental Vascularization Using Contrast Ultrasound
ClinicalTrials.gov ID: NCT06497959
What this study is testing
What is SonoVue?
SonoVue is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fetal growth restriction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 48 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64, women only
You may be able to join if
- 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...
- Affiliated to the social security system or benefit from such a system,
You likely can't join if
- 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...
- Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code:
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.