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

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696223
• Other study ID #: 2022PI187-343
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Fetal growth restriction of antenatal diagnosis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Other:
• Ultrasound
Doppler mesure

Locations

Country	Name	City	State
France	Maternite Regionale et Universitaire de Nancy	Nancy	Meurthe-et-moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)