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

Preeclampsia Clinical Trial

— earlyGRAFD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05284474
• Other study ID #: PR(AMI)113/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Manel Mendoza, MD, PhD
• Phone: +34934893000
• Email: manel.mendoza[@]vallhebron.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: December 30, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Placenta Diseases
• Pre-Eclampsia
• Preeclampsia

Intervention

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)

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de A Coruña	A Coruña
Spain	Hospital Universitario General de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Dexeus	Barcelona
Spain	Vall d'hebron Barcelona Hospital Campus	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	Sevilla
Spain	Virgen Macarena	Sevilla
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

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Instituto de Salud Carlos III, Roche Diagnostics GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal and Neonatal complications	stillbirth, neonatal death, artery cord pH =7.0, respiratory distress syndrome, required invasive ventilatory support, grade III or IV intraventricular hemorrhage, neonatal sepsis, necrotizing enterocolitis, neonatal seizures, pneumonia, meningitis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy, Apgar score <7 at 5 minutes, or elective delivery at <28 weeks of gestation.	During pregnancy and up to 28 days after delivery
Primary	Composite adverse maternal outcome	Progression to PE with severity features; progression to hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome (LDH >600 IU/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevated more than twice the upper limit of normal, and the platelet count less than 100 X 109/L); eclampsia, stroke, hepatic hematoma or rupture; oliguria (urine output of <400 mL during 24 hours, or need for treatment with furosemide to maintain urine output at >400 mL for 24 hours); cardiovascular dysfunction (need for inotropic support, left ventricle failure, or myocardial infarction); placental abruption; maternal death; maternal admission to intensive care unit >48 hours, and/or requirement for blood transfusion.	During pregnancy and up to 28 days after delivery
Secondary	Maternal perceived stress	Mean and sd or median and IQR of the score obtained in the perceived stress scale in each group	At inclusion and 4 weeks later
Secondary	Other perinatal outcomes	transient tachypnea, non-invasive ventilatory support, hypoglycemia, neonatal jaundice (treated with phototherapy), rate of elective deliveries < 30 weeks, <34 weeks and < 37 weeks for FGR and/or PE, birthweight <3 rd and <10th percentiles, mode of delivery (vaginal, instrumental vaginal delivery and Cesarean), rate of Cesarean delivery for abnormal CTG, median maternal stay in ICU, median neonatal stay in N-ICU, maternal corticosteroids (single dose, complete course), prenatal magnesium sulfate (at least 4h) for preterm delivery.	During pregnancy and up to 28 days after delivery
Secondary	Number of ultrasounds per participant	Mean and sd or median and IQR in each group	During pregnancy (before and after 37 weeks)