Examining placental blood flow using contrast ultrasound in pregnancies with growth restriction
Contribution of Contrast-Enhanced Ultrasound (CES) in the Fetal-placental Circulation Study
This study is testing how well blood flows in the placenta of women having a medical termination of pregnancy, comparing those with and without fetal growth restriction to learn more about these conditions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT06497959 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate placental vascularization in women undergoing medical termination of pregnancy, comparing those with fetal growth restriction to those without. It employs contrast-enhanced ultrasound (SonoVue) to assess placental blood flow and function in vivo, which is crucial for understanding the pathophysiology of conditions like preeclampsia and intrauterine growth restriction. The study will include 30 women over a 48-month period at the CHRU de Nancy, focusing on the differences in placental perfusion between the two groups. This approach seeks to provide insights that could lead to better management of pregnancies affected by these complications.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 and older, with singleton pregnancies between 16 and 38 weeks gestation, who have requested a medical termination of pregnancy.
Not a fit: Patients who do not speak French or have medical conditions contraindicating the use of SonoVue will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of placental function and improve outcomes for pregnancies affected by growth restriction.
How similar studies have performed: While studies on placental vascularization exist, this specific approach using contrast-enhanced ultrasound in the context of fetal growth restriction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nancy
- CHRU de NANCY — Nancy, France (Recruiting)
Study contacts
- Study coordinator: Matthieu DAP, Doctor
- Email: m.dap@chru-nancy.fr
- Phone: +333 83 34 36 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.