Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction - ANGIOPAG

NCT05151289 | Unknown

• 2 other identifiers: APHP1904722019-A01116-51
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR.

Conditions

Intrauterine Growth Restriction; Fetal Growth Restriction (FGR)

Keywords

sFlt1; PlGF; IUGR; intrauterine growth restriction; fetal growth restriction

Outcome Measures

Primary Outcomes (1)

• To compare the PlGF / sFlt-1 ratio and placental lesions to confirm the diagnosis of vascular intrauterine growth retardation

  The etiological diagnosis will be confirmed as vascular if characteristic lesions are identified on placental analysis. Lesions of maternal vascular malperfusion have been described and are those used in scientific literature. These characteristics are placental infarcts, decidual arteriopathy, and villous hypoplasia.

  34+6 Weeks of Gestation

Secondary Outcomes (7)

• Delay between inclusion and birth

  21 weeks after inclusion

• Occurrence of preeclampsia

  21 weeks after inclusion

• Gestational age at birth

  maximum 21 weeks after inclusion

• Birth weight

  maximum 21 weeks after inclusion

• Newborn evaluation (presence of birth defects)

  maximum 21 weeks after inclusion

Study Arms (1)

Patients consulting in one of the participating centers for intra uterine growth restriction.

EXPERIMENTAL

All included patients

Biological: Blood test at time of inclusion for sFlt-1/PlGF ratio; Biological: Follow-up blood test 2 to 4 weeks after inclusion; Diagnostic Test: Placenta analysis for all included patients, even in case of normal birthweight

Interventions

Blood test at time of inclusion for sFlt-1/PlGF ratio BIOLOGICAL

As part of the research, a blood sample is taken to measure the sFLT-1 and PlGF ratio at the inclusion visit.

Patients consulting in one of the participating centers for intra uterine growth restriction.

Follow-up blood test 2 to 4 weeks after inclusion BIOLOGICAL

As part of the research, a blood sample is taken to measure the sFLT-1 and PlGF ratio at the follow-up visit (about 2-4 weeks after inclusion). This second sample is not mandatory for the evaluation of the study's main endpoint.

Patients consulting in one of the participating centers for intra uterine growth restriction.

Placenta analysis for all included patients, even in case of normal birthweight DIAGNOSTIC_TEST

After delivery, the placenta of each included patient is sent to anatomo-pathology (even in case of normal weight of the baby at birth). An anatomopathologist referent, designated for the study in each center, performs an analysis (aware of the clinic but not of the sFLT-1/PlGF ratio results), according to the benchmark criteria grid. Local analysis will classify the placenta as "vascular IUGR" or "nonvascular IUGR".

Patients consulting in one of the participating centers for intra uterine growth restriction.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• Singleton pregnancy
• Date of conception evaluated by ultrasound \< 14 WG
• Consulting in one of the 3 participating centers for IUGR
• Estimated fetal weight \< 5th centile (according to Hadlock 3 et CFEF)
• Between 22+0 WG et 34+6 WG

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Louis Mourier

Colombes, 92700, France

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

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

Study Officials

• Jeanne Sibiude, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanne Sibiude, MD, PhD

CONTACT

01 40 60 66 11; jeanne.sibiude@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Regarding the placenta study : for each patient included, the placenta is sent to anatomo-pathology and a referent anatomo-pathologist designated for the study in each center makes an analysis (blind of dosages of sFlt-1/PlGF but not of the clinic)
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients consulting in one of the participating centers for intra uterine growth restriction.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: December 9, 2021
• Study Start: January 8, 2020
• Primary Completion: January 29, 2022
• Study Completion: January 29, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-08

Locations

FR (1)