Universal screening programme for cytomegalovirus infection in the first trimester of pregnancy: study protocol for an observational multicentre study in the area of Barcelona (CITEMB study).
Fetal medicine
Maternal medicine
Prenatal diagnosis
Public health
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
19 07 2023
19 07 2023
Historique:
medline:
24
7
2023
pubmed:
21
7
2023
entrez:
20
7
2023
Statut:
epublish
Résumé
Congenital cytomegalovirus (cCMV) is the leading cause of non-genetic sensorineural hearing loss and one of the main causes of neurological disability. Despite this, no universal screening programme for cCMV has been implemented in Spain. A recent study has shown that early treatment with valaciclovir, initiated in the first trimester and before the onset of signs in the fetus, reduces the risk of fetal infection. This finding favours the implementation of a universal screening programme for cCMV.The aim of this study is to evaluate the performance of a universal screening programme for cCMV during the first trimester of pregnancy in a primary care setting. This is an observational multicentre cohort study. The study will be conducted in four primary care settings from the Northern Metropolitan Barcelona area and three related hospitals and will last 3 years and will consist of a recruitment period of 18 months.In their first pregnancy visit, pregnant women will be offered to add a CMV serology test to the first trimester screening tests. Pregnant women with primary infection will be referred to the reference hospital, where they will continue treatment and follow-up according to the clinical protocol of the referral hospital, which includes treatment with valacyclovir. A CMV-PCR will be performed at birth on newborns of mothers with primary infection, and those who are infected will undergo neonatal follow-up for at least 12 months of life.For the analysis, the acceptance rate, the prevalence of primary CMV infections and the CMV seroprevalence in the first trimester of pregnancy will be studied. Ethical approval was obtained from the University Institute Foundation for Primary Health Care Research Jordi Gol i Gurina Ethics Committee 22/097-P dated 27 April 2022.
Identifiants
pubmed: 37474185
pii: bmjopen-2023-071997
doi: 10.1136/bmjopen-2023-071997
pmc: PMC10357649
doi:
Substances chimiques
Valacyclovir
MZ1IW7Q79D
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e071997Investigateurs
Rocio Rodriguez López
(RR)
Margarita Mendoza Ariza
(MM)
Meritxell Fors Andreu
(MF)
Carolina Exposito Moreno
(CE)
Cristina Garcia López
(CG)
Elena Scazzocchio Dueñas
(ES)
Irene Fernández Torm
(IF)
Loida Lucas Porras
(LL)
Sara Albero Jiménez
(SA)
Julia Arquillos Jiménez
(JA)
Alicia Capel Tatjer
(AC)
Irene Domínguez García
(ID)
Yolanda Reyes Nef
(YR)
Asun Teva Calahorro
(AT)
Montse Ortiz González
(MO)
Esther Rebull López
(ER)
Rocío Garrido Carreño
(RG)
Sandra Olivera Lindez
(SO)
Olga Gracia Salazar
(OG)
Marta Calveiro Hermo
(MC)
Jordina Munros Feliu
(JM)
Astrid Francesch Campi
(AF)
Laia Alcoverro Bedos
(LA)
Juliana Esperalba
(J)
Carlota Rodó
(C)
Teresa Higueras Sanz
(TH)
Elida Vázquez
(E)
Gema Fernandez Rivas
(GF)
Ana Sancho Cerro
(AS)
Marta López
(M)
Karen Castillo-Viteri
(K)
Giorgia Sebastiani
(G)
Claudia Fortuny
(C)
María Rosa Escriche Marco
(MR)
Maria Pilar Sancho Perez
(MP)
Ana Barluenga Perez-Cossio
(AB)
Lucia Alcaraz Vidal
(LA)
Cristina Morote Muñoz
(CM)
Esther Cerro Hernandez
(EC)
Marina Raja Carcaña
(MR)
Marta Xiville Sole
(MX)
Mercedes Rey Arijón
(MR)
Miriam Garcia Sanchez
(MG)
Mª Teresa Sanchez Casado
(MT)
Natalia Dueñas Herrero
(ND)
Paula Amoros Ferrer
(PA)
Pilar Cabrerizo Las Heras
(PCL)
Raquel Martinez Mondejar
(RM)
Cristina Del Viso Lajara
(CDV)
Maria Mercedes Vicente Fernández
(MMV)
Raquel Antón da Silva
(RAD)
Núria Tosquella Roig
(NT)
Berta Serrano Ejarque
(BS)
Júlia Mitjans Carrasco
(JM)
Silvia Martinez Rubiño
(SM)
Gemma Prieto Sanchez
(GP)
Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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