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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05696223
Collaborator
(none)
220
1
7
31.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Ultrasound

Study Design

Study Type:
Observational
Actual Enrollment :
220 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction
Actual Study Start Date :
Jun 1, 2022
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Early fetal growth restriction

Fetal growth restriction diagnosed before 32 SA

Other: Ultrasound
Doppler mesure

Late fetal growth restriction

Fetal growth restriction diagnosed after 32 SA

Other: Ultrasound
Doppler mesure

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • Fetal growth restriction of antenatal diagnosis
Exclusion Criteria:
  • Twin pregnancies, non-isolated IUGR, post-natal diagnosis of FGR and incomplete records

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maternite Regionale et Universitaire de Nancy Nancy Meurthe-et-moselle France 54000

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TOURNIER Mathilde, Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05696223
Other Study ID Numbers:
  • 2022PI187-343
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by TOURNIER Mathilde, Doctor, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023