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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

Tracking Information
First Submitted Date February 27, 2019
First Posted Date March 1, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date March 12, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2019)
  • Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging [ Time Frame: 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)
Official Title Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women
Condition Preeclampsia and Intrauterine Growth Restriction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2019)
165
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnant women
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chloé Arthuis, Dr chloe.arthuis@chu-nantes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03860103
Other Study ID Numbers RC19_0049
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators
  • Jean-Luc GENNISSON
  • Anthony NOVELL
  • CNRS UMR 8081, Unviersité Paris Sud
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date April 2019