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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05284474
Other study ID # PR(AMI)113/2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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