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Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
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.
Official title: Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2024-06-03
Completion Date
2026-12-30
Last Updated
2024-06-04
Healthy Volunteers
No
Interventions
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)
Locations (27)
Complejo Hospitalario Universitario de A Coruña
A Coruña, Spain
Hospital Universitario General de Alicante
Alicante, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Vall d'hebron Barcelona Hospital Campus
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Dexeus
Barcelona, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitario de Getafe
Getafe, Spain
Hospital Universitario de Cabueñes
Gijón, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Universitari Son Llàtzer
Palma de Mallorca, Spain
Corporació Sanitària Parc Taulí
Sabadell, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Virgen Macarena
Seville, Spain
Hospital Universitario Joan XXIII de Tarragona
Tarragona, Spain
Consorci Sanitari de Terrassa
Terrassa, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain