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Clinical Trials/NCT05696223
NCT05696223CompletedNot Applicable

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

Central Hospital, Nancy, France1 site in 1 country220 target enrollmentStarted: June 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
220
Locations
1
Primary Endpoint
evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Fetal growth restriction of antenatal diagnosis

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies(during pregnancy (6 month per patient maximum))

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

TOURNIER Mathilde

Doctor

Central Hospital, Nancy, France

Study Sites (1)

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