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

NCT05696223 | Completed DMC

• 1 other identifier: 2022PI187-343
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

Fetal Growth Retardation, Doppler, perinatale outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Early fetal growth restriction

Fetal growth restriction diagnosed before 32 SA

Other: Ultrasound

Late fetal growth restriction

Fetal growth restriction diagnosed after 32 SA

Other: Ultrasound

Interventions

Ultrasound OTHER

Doppler mesure

Early fetal growth restriction; Late fetal growth restriction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All the FGR of antenatal diagnosis, who were confirmed by an ultrasound made by a referring Doctor and involved in a specific management for FGR, during this period of 2 years were included

You may qualify if:

• Fetal growth restriction of antenatal diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternite Regionale et Universitaire de Nancy

Nancy, Meurthe-et-moselle, 54000, France

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)