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

Completed

• Conditions: Fetal Growth Retardation
• Interventions: Other: Ultrasound

• Registration Number: NCT05696223
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-12-01
• Status Verified: 2023-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-13
• Last Update Submitted: 2023-01-13
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• Fetal growth restriction of antenatal diagnosis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early fetal growth restriction	Ultrasound	Fetal growth restriction diagnosed before 32 SA
Late fetal growth restriction	Ultrasound	Fetal growth restriction diagnosed after 32 SA

Primary Outcome Measures

Name	Time	Method
evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies	during pregnancy (6 month per patient maximum)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Maternite Regionale et Universitaire de Nancy; 🇫🇷 Nancy, Meurthe-et-moselle, France