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OpenTrials
Completed

NCT Number: NCT05696223

Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction

When a FGR is diagnose, the challenge in his monitoring is to assess the benefit-risk balance between continuing the pregnancy in order to limit complications related to prematurity and birth in order to minimize any risk of fetal death in utero. By able to know the characteristics of fetal deteriorations and its relationship with fetal and neonatal outcomes could be a thankful help in this decision. The placental insufficiency is by far the most common cause of FGR (32)(miller 2008). This effect can be documented thanks to ultrasound examinations to study fetal growth and Doppler of umbilical arteries for the placenta, the middle cerebral artery for the brain perfusion and the Ductus Venosus for the cardiac effects of placental dysfunction. The apparition of Doppler abnormalities suggests a deterioration of the disease and leads to several changes in clinical FGR management. Nevertheless, at this time, very few studies allow us to predict the time util the degradation and their impact on perinatal outcomes.

The primary aim of this study was to evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies. The secondary aim was to evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Maternite Regionale et Universitaire de Nancy

Nancy, Meurthe-et-moselle, 54000, France

Who can participate

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

Inclusion criteria

  • Fetal growth restriction of antenatal diagnosis

Exclusion criteria

  • Twin pregnancies, non-isolated IUGR, post-natal diagnosis of FGR and incomplete records

Treatment and study plan

ultrasound

Other

Doppler mesure

Primary outcomes

  1. evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies

    Time frame: during pregnancy (6 month per patient maximum)

Secondary outcomes

  1. evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies

    Time frame: during pregnancy (6 month per patient maximum)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

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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