Contribution of Contrast-Enhanced Ultrasound (CES) in the Fetal-placental Circulation Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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. No etiological treatment for these pathologies is available. Inducing birth is the only way to prevent the occurrence of these complications (such as fetal death in utero. Therefore, a better understanding of placental vascularization under pathological and physiological conditions is necessary. This placental vascularization evolves throughout gestation. Histological studies have improved our knowledge of placental vascular pathologies; however, these are ex vivo data that only provide an incomplete reflection of placental function. In vivo placental studies are therefore essential to understand the mechanisms of placental perfusion. Currently, these studies are limited because the available tools (such as placental Doppler) do not allow for the separate study of maternal placental flow from fetal flow. However, histological evidence clearly establishes maternal placental vascular involvement in IUGR. It would therefore be interesting to study maternal and fetal placental vascularization separately. The development of new in vivo imaging exploration techniques will help to better understand placental pathologies. In obstetrics, CES would offer the opportunity to study in vivo placental vascularization in a segmented manner (maternal versus fetal side independently) since the microbubbles do not cross the placental barrier. Animal studies show no toxic effects on fetal development nor any crossing of the placental barrier. In humans, the innovative use of this contrast agent has allowed for a better understanding of placental vascularization in the first trimester of pregnancy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
CHRU de NANCY
RECRUITING
Nancy
Contact Information
Primary
Matthieu DAP, Doctor
m.dap@chru-nancy.fr
+333 83 34 36 11
Backup
Juliette LEFEBVRE, Junior doctor
J.LEFEBVRE@chru-nancy.fr
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2029-04-10
Participants
Target number of participants: 30
Treatments
Experimental: Non-growth restriction group (control group)
Fetuses not affected by growth pathology, defined by an estimated weight greater than the 10th percentile at ultrasound
Experimental: Severe growth restriction group
Severe growth restriction defined by an estimated fetal weight below the 3rd percentile on ultrasound
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov