NCT05284474

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fetal Growth Retardation
• Preeclampsia
• Placenta Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)	soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) will be incorporated to the management of early-onset small fetuses (estimated fetal weight ≤10th percentile)

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-09-01
• Completion: 2026-12-30
• First posted: 2022-03-17
• Last updated: 2024-06-04

Locations

27 sites across 1 country: Spain