Authorised Therapeutic confirmatory (Phase III) Fetal growth restriction

Study of placental vascularization using contrast ultrasound

EU CTIS ID: 2023-506936-34-00

What this study is testing

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

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Adult woman (age ≥18 years)
  • Gestational age between 16 GW + 0 days and 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 CHRU de Nancy
  • 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).

You likely can't join if

  • 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.
  • 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
  • Person who do not speak French

The study team makes the final eligibility decision.

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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.