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Completed

NCT Number: NCT03860103

Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)

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.

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Key information

Conditions

Preeclampsia and Intrauterine Growth Restriction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Hypertension, Pregnancy-Induced Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2019
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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