Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)

Completed

• Conditions: Preeclampsia and Intrauterine Growth Restriction

• Registration Number: NCT03860103
• Lead Sponsor: Nantes University Hospital

Brief Summary

To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. Thus, the investigators propose to study placental microcirculation with a more efficient Doppler than conventional Doppler use in clinical practice. The Ultrafast Doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. Moreover, this Doppler could discriminate maternal and fetal vascularization.

The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage preeclampsia and IUGR during pregnancy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Start: 2019-04-01
• Status Verified: 2022-03
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

Inclusion Criteria

• Patient who accepted to participate in the study
• Woman over 18 years old
• Affiliated to a social security scheme
• Mono-fetal pregnancy
• Patients with normal pregnancy between 11 and 42 weeks of amenorrhea
• Patients hospitalized for preeclampsia and / or intrauterine growth retardation, beyond 20 weeks of amenorrhea

Exclusion Criteria

• Minors, adults under guardianship, protected persons
• Not affiliated to a social security scheme
• Multiple pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging	from the 12 week of gestation
Quantitative analysis (flow rates) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler	from the 12 week of gestation

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France