Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03860103

Collaborator

(none)

165

Enrollment

Location

35.5

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia and Intrauterine Growth Restriction

Study Design

Study Type:

Observational

Actual Enrollment :

165 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Mar 16, 2022

Actual Study Completion Date :

Mar 16, 2022

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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