- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860103
Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)
Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nantes, France, 44093
- Nantes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging
Time Frame: from the 12 week of gestation
|
from the 12 week of gestation
|
Quantitative analysis (flow rates) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler
Time Frame: from the 12 week of gestation
|
from the 12 week of gestation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC19_0049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preeclampsia and Intrauterine Growth Restriction
-
University of British ColumbiaTerminatedIntrauterine Growth Restriction (IUGR) | Fetal Growth Restriction (FGR)Canada
-
Assiut UniversityCompleted
-
Ain Shams UniversityUnknownIntrauterine Growth Restriction AsymmetricalEgypt
-
Johns Hopkins UniversityWithdrawnFetal Growth Retardation | Intrauterine Growth Restriction | Intrauterine Growth Retardation | Fetal Growth Restriction
-
Assiut UniversityCompletedIntrauterine Growth Restriction (IUGR)
-
Tel-Aviv Sourasky Medical CenterUnknownPregnancy Complications | Preeclampsia | Placental Abruption | Intrauterine Fetal Death | Intrauterine Fetal Growth RestrictionIsrael
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNCompletedPreeclampsia | Intrauterine Growth RestrictionSpain
-
Hospices Civils de LyonUnknown
-
Assistance Publique - Hôpitaux de ParisRecruitingIntrauterine Growth Restriction | Fetal Growth Restriction (FGR)France
-
University of OuluBayer; Kuopio University Hospital; Tampere UniversityCompletedPregnancy | Preeclampsia | Intrauterine Fetal Growth Restriction | Miscarriage Less Than 12 Gestational Weeks | Extrauterine PregnancyFinland