Clinical trial NCT05284474: Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler
Official title: Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fetal Growth Retardation
Preeclampsia
Placenta Diseases
Keywords: fetal growth restriction
small for gestational age
PlGF
sFlt-1
Doppler
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Roche Diagnostics GmbH
First posted: 2022-03-17
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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 outcomes:
measure: Fetal and Neonatal complications
timeFrame: During pregnancy and up to 28 days after delivery
measure: Composite adverse maternal outcome
timeFrame: During pregnancy and up to 28 days after delivery
Secondary outcomes:
measure: Maternal perceived stress
timeFrame: At inclusion and 4 weeks later
measure: Other perinatal outcomes
timeFrame: During pregnancy and up to 28 days after delivery
measure: Number of ultrasounds per participant
timeFrame: During pregnancy (before and after 37 weeks)
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Alicante
country: Spain
facility: Hospital Universitario General de Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Vall d'hebron Barcelona Hospital Campus
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Materno Infantil de Gran Canaria
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Llàtzer
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Virgen Macarena
city: Tarragona
country: Spain
facility: Hospital Universitario Joan XXIII de Tarragona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
city: Torrejón De Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Vall d'Hebron Institut de Recerca (VHIR)
name: Manel Mendoza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: