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

NCT ID: NCT05696223

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-01

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

Conditions

Fetal Growth Retardation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Early fetal growth restriction

Fetal growth restriction diagnosed before 32 SA

Ultrasound

Intervention Type: OTHER

Doppler mesure

Late fetal growth restriction

Fetal growth restriction diagnosed after 32 SA

Ultrasound

Intervention Type: OTHER

Doppler mesure

Interventions

Ultrasound

Doppler mesure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Fetal growth restriction of antenatal diagnosis

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

TOURNIER Mathilde

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maternite Regionale et Universitaire de Nancy

Nancy, Meurthe-et-moselle, France

Countries

France

Other Identifiers

2022PI187-343

Identifier Type: -

Identifier Source: org_study_id