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

Background: 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...

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Autores: Garcia-Manau, P, Mendoza, M, Bonacina, E, Martin-Alonso, R, Martin, L, Palacios, A, Sanchez, ML, Lesmes, C, Hurtado, I, Perez, E, Tubau, A, Ibañez, P, Alcoz, M, Valiño, N, Moreno, E, Borrero, C, Garcia, E, Lopez-Quesada, E, Diaz, S, Broullon, JR, Teixidor, M, Chulilla, C, Gil, MM, Lopez, M, Candela-Hidalgo, A, Salinas-Amoros, A, Moreno, A, Morra, F, Vaquerizo, O, Soriano, B, Fabre, M, Gomez-Valencia, E, Cuiña, A, Alayon, N, Sainz, JA, Vives, A, Esteve, E, Ocaña, V, López, MA, Maroto, A, Carreras, E
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p10085
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones10085
https://www.researchprotocols.org/2022/10/e37452
Access Level:acceso abierto
Palabra clave:fetal growth restriction
small for gestational age
PlGF
sFlt-1
Doppler
angiogenic factors
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spelling 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 TrialGarcia-Manau, PMendoza, MBonacina, EMartin-Alonso, RMartin, LPalacios, ASanchez, MLLesmes, CHurtado, IPerez, ETubau, AIbañez, PAlcoz, MValiño, NMoreno, EBorrero, CGarcia, ELopez-Quesada, EDiaz, SBroullon, JRTeixidor, MChulilla, CGil, MMLopez, MCandela-Hidalgo, ASalinas-Amoros, AMoreno, AMorra, FVaquerizo, OSoriano, BFabre, MGomez-Valencia, ECuiña, AAlayon, NSainz, JAVives, AEsteve, EOcaña, VLópez, MAMaroto, ACarreras, Efetal growth restrictionsmall for gestational agePlGFsFlt-1Dopplerangiogenic factorsBackground: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov NCT04502823; https://clinicaltrials.gov/ct2/show/NCT04502823JMIR PUBLICATIONS, INC2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://isabial.portalinvestigacion.com/publicaciones10085https://www.researchprotocols.org/2022/10/e37452JMIR Research ProtocolsISSN: 19290748reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicanteinstname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)Inglésinfo:eu-repo/semantics/openAccessoai:isabial.fundanetsuite.com:p100852026-06-12T10:20:37Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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, P
fetal growth restriction
small for gestational age
PlGF
sFlt-1
Doppler
angiogenic factors
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Garcia-Manau, P
Mendoza, M
Bonacina, E
Martin-Alonso, R
Martin, L
Palacios, A
Sanchez, ML
Lesmes, C
Hurtado, I
Perez, E
Tubau, A
Ibañez, P
Alcoz, M
Valiño, N
Moreno, E
Borrero, C
Garcia, E
Lopez-Quesada, E
Diaz, S
Broullon, JR
Teixidor, M
Chulilla, C
Gil, MM
Lopez, M
Candela-Hidalgo, A
Salinas-Amoros, A
Moreno, A
Morra, F
Vaquerizo, O
Soriano, B
Fabre, M
Gomez-Valencia, E
Cuiña, A
Alayon, N
Sainz, JA
Vives, A
Esteve, E
Ocaña, V
López, MA
Maroto, A
Carreras, E
author Garcia-Manau, P
author_facet Garcia-Manau, P
Mendoza, M
Bonacina, E
Martin-Alonso, R
Martin, L
Palacios, A
Sanchez, ML
Lesmes, C
Hurtado, I
Perez, E
Tubau, A
Ibañez, P
Alcoz, M
Valiño, N
Moreno, E
Borrero, C
Garcia, E
Lopez-Quesada, E
Diaz, S
Broullon, JR
Teixidor, M
Chulilla, C
Gil, MM
Lopez, M
Candela-Hidalgo, A
Salinas-Amoros, A
Moreno, A
Morra, F
Vaquerizo, O
Soriano, B
Fabre, M
Gomez-Valencia, E
Cuiña, A
Alayon, N
Sainz, JA
Vives, A
Esteve, E
Ocaña, V
López, MA
Maroto, A
Carreras, E
author_role author
author2 Mendoza, M
Bonacina, E
Martin-Alonso, R
Martin, L
Palacios, A
Sanchez, ML
Lesmes, C
Hurtado, I
Perez, E
Tubau, A
Ibañez, P
Alcoz, M
Valiño, N
Moreno, E
Borrero, C
Garcia, E
Lopez-Quesada, E
Diaz, S
Broullon, JR
Teixidor, M
Chulilla, C
Gil, MM
Lopez, M
Candela-Hidalgo, A
Salinas-Amoros, A
Moreno, A
Morra, F
Vaquerizo, O
Soriano, B
Fabre, M
Gomez-Valencia, E
Cuiña, A
Alayon, N
Sainz, JA
Vives, A
Esteve, E
Ocaña, V
López, MA
Maroto, A
Carreras, E
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv fetal growth restriction
small for gestational age
PlGF
sFlt-1
Doppler
angiogenic factors
topic fetal growth restriction
small for gestational age
PlGF
sFlt-1
Doppler
angiogenic factors
description Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov NCT04502823; https://clinicaltrials.gov/ct2/show/NCT04502823
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://isabial.portalinvestigacion.com/publicaciones10085
https://www.researchprotocols.org/2022/10/e37452
url https://isabial.portalinvestigacion.com/publicaciones10085
https://www.researchprotocols.org/2022/10/e37452
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv JMIR PUBLICATIONS, INC
publisher.none.fl_str_mv JMIR PUBLICATIONS, INC
dc.source.none.fl_str_mv JMIR Research Protocols
ISSN: 19290748
reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
instname_str Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
reponame_str r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
collection r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,81155

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