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ClinicalTrials.gov ID

NCT05284474

Lead Sponsor

Hospital Universitari Vall d'Hebron Research InstituteOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

340Estimated

Last Update Posted

Jun 4, 2024Actual

Start Date

Jun 3, 2024Estimated

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Dec 30, 2026Estimated

Official Title

Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)

Brief Summary

This is a multicentre, open-label, randomized controlled trial. A total of 340 singleton pregnancies with an EFW ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.

• Fetal Growth Retardation
• Preeclampsia
• Placenta Diseases

• soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Pregnant women of at least 18 years old
• Singleton pregnancy
• Ultrasonographic EFW ≤10th percentile between 26+0 and 31+6 weeks of gestation
• Gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates.

Exclusion Criteria:

• Major fetal malformations or genetic disorders
• Fetal death
• Refusal to give informed consent
• Stage IV FGR

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Hospital Universitari Vall d'Hebron Research InstituteOTHER

Collaborators

Instituto de Salud Carlos IIIOTHER_GOV

Roche Diagnostics GmbHINDUSTRY

ana.palacios.marques@gmail.com

ivan.hurtado85@gmail.com

jullmo@santpau.cat

pilpra@dexeus.com

manaya2404@gmail.com

ada.herrington@gmail.com

elenapintadoparedes@gmail.com

estherpcarbajo@hotmail.com

mcarmenjimenezhernandez@gmail.com

sb.rabassa@gmail.com

ricardo.saviron@salud.madrid.org

mariavilacortes@gmail.com

bea180680@gmail.com

annmorenoba@gmail.com

carlotaborrero@gmail.com

evam.carmona.sspa@juntadeandalucia.es

vivesangels@gmail.com

evalq@hotmail.com

raqmaral@gmail.com

patribanez@hotmail.com