The Fetal Growth Restriction at Term Managed by Angiogenic Factors Versus Feto-Maternal Doppler (GRAFD) Trial to Avoid Adverse Perinatal Outcomes : Protocol for a Multicenter, Open-Label, Randomized Controlled Trial
Garcia-Manau, Pablo (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Mendoza, Manel (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Bonacina, Erika (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Martin-Alonso, Raquel (Universidad Francisco de Vitoria)
Martin, Lourdes (Universitat Rovira i Virgili)
Palacios, Ana (Universidad Miguel Hernández de Elche)
Sanchez, Maria Luisa (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
Lesmes Heredia, Cristina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Hurtado, Ivan (Institut Germans Trias i Pujol)
Perez, Esther (Universidad de Oviedo)
Tubau Navarra, Albert (Universitat de les Illes Balears)
Ibañez, Patricia (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Alcoz, Marina (Universitat de Vic)
Valiño, Nuria (Universidade da Coruña)
Moreno, Elena (Universidad Miguel Hernández de Elche)
Borrero, Carlota (Universidad de Sevilla)
Garcia, Esperanza (Universitat Internacional de Catalunya)
Lopez-Quesada, Eva (Universitat de Barcelona)
Díaz Rodríguez, Sonia (Universidad Europea de Madrid)
Broullon, Jose Roman (Universidad de Cádiz)
Teixidor, Mireia (Universitat de Girona)
Chulilla, Carolina (Universidad de La Laguna)
Gil, Maria M (Universidad Francisco de Vitoria)
Lopez, Monica (Universitat Rovira i Virgili)
Candela-Hidalgo, Amparo (Universidad Miguel Hernández de Elche)
Salinas-Amoros, Andrea (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
Moreno Baró, Anna (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Morra, Francesca (Institut Germans Trias i Pujol)
Vaquerizo, Oscar (Universidad de Oviedo)
Soriano, Beatriz (Universitat de les Illes Balears)
Fabre, Marta (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Gomez-Valencia, Elena (Universitat de Vic)
Cuiña, Ana (Universidade da Coruña)
Alayon, Nicolas (Universidad Miguel Hernández de Elche)
Sainz, Jose Antonio (Universidad de Sevilla)
Vives, Angels (Universitat Internacional de Catalunya)
Esteve, Esther (Universitat de Barcelona)
Ocaña, Vanesa (Universidad Europea de Madrid)
López, Miguel Ángel (Universidad de Cádiz)
Maroto, Anna (Universitat de Girona)
Carreras Moratonas, Elena (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Universitat Autònoma de Barcelona

Data:	2022
Resum:	Fetal smallness affects 10% of pregnancies. Small fetuses are at a higher risk of adverse outcomes. Their management using estimated fetal weight and feto-maternal Doppler has a high sensitivity for adverse outcomes; however, more than 60% of fetuses are electively delivered at 37 to 38 weeks. On the other hand, classification using angiogenic factors seems to have a lower false-positive rate. Here, we present a protocol for the Fetal Growth Restriction at Term Managed by Angiogenic Factors Versus Feto-Maternal Doppler (GRAFD) trial, which compares the use of angiogenic factors and Doppler to manage small fetuses at term. The primary objective is to demonstrate that classification based on angiogenic factors is not inferior to estimated fetal weight and Doppler at detecting fetuses at risk of adverse perinatal outcomes. This is a multicenter, open-label, randomized controlled trial conducted in 20 hospitals across Spain. A total of 1030 singleton pregnancies with an estimated fetal weight ≤10th percentile at 36+0 to 37+6 weeks+days 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, cases with a soluble fms-like tyrosine kinase to placental growth factor ratio ≥38 will be classified as having fetal growth restriction; otherwise, they will be classified as being small for gestational age. In both arms, the fetal growth restriction group will be delivered at ≥37 weeks and the small for gestational age group at ≥40 weeks. We will assess differences between the groups by calculating the relative risk, the absolute difference between incidences, and their 95% CIs. Recruitment for this study started on September 28, 2020. The study results are expected to be published in peer-reviewed journals and disseminated at international conferences in early 2023. The angiogenic factor-based protocol may reduce the number of pregnancies classified as having fetal growth restriction without worsening perinatal outcomes. Moreover, reducing the number of unnecessary labor inductions would reduce costs and the risks derived from possible iatrogenic complications. Additionally, fewer inductions would lower the rate of early-term neonates, thus improving neonatal outcomes and potentially reducing long-term infant morbidities ClinicalTrials. gov NCT04502823; https://clinicaltrials. gov/ct2/show/NCT04502823 DERR1-10. 2196/37452.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Fetal growth restriction ; Small for gestational age ; PlGF ; Sflt-1 ; Doppler ; Angiogenic factors
Publicat a:	JMIR Research Protocols, Vol. 11 (october 2022) , ISSN 1929-0748

DOI: 10.2196/37452
PMID: 36222789

14 p, 466.8 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats