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Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860103
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Jean-Luc GENNISSON
Anthony NOVELL
CNRS UMR 8081, Unviersité Paris Sud
Information provided by (Responsible Party):
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.


Condition or disease
Preeclampsia and Intrauterine Growth Restriction

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Study Type : Observational
Estimated 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 : March 12, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging [ Time Frame: from the 12 week of gestation ]
  2. Quantitative analysis (flow rates) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler [ Time Frame: from the 12 week of gestation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860103


Contacts
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Contact: Chloé Arthuis, Dr chloe.arthuis@chu-nantes.fr

Locations
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France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Chloë Arthuis, PH       chloe.arthuis@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Jean-Luc GENNISSON
Anthony NOVELL
CNRS UMR 8081, Unviersité Paris Sud
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03860103    
Other Study ID Numbers: RC19_0049
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
microDoppler
placenta
preeclampsia
intrauterine growth restriction
Additional relevant MeSH terms:
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Pre-Eclampsia
Fetal Growth Retardation
Placental Insufficiency
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Placenta Diseases