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. 2023 Jul 19;13(7):e071997.
doi: 10.1136/bmjopen-2023-071997.

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)

Maria Angeles Sanchez-Durán #  1 , Nerea Maiz #  2 , Liudmila Liutsko  3   4 , Jofre Bielsa-Pascual  5 , Rosa García-Sierra  5   6 , Aneta Monika Zientalska  7 , Inés Velasco  7 , Eva Vazquez  8 , Olga Gracia  9 , Aleida Ribas  10 , Nuria Sitja  11 , Maria Nadales  12 , Cristina Martinez  13   14 , Anna Gonce  14   15 , Marie Antoinette Frick  16 , Mercedes Guerrero-Martínez  11   17 , Concepción Violán  5   18 , Pere Torán  5   18 , Gemma Falguera-Puig  19   20 , Roser Gol  12   17 ; CITEMB Group
Collaborators, Affiliations

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)

Maria Angeles Sanchez-Durán et al. BMJ Open. .

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Keywords: Fetal medicine; Maternal medicine; Prenatal diagnosis; Public health.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
The CITEMB (universal screening programme for cytomegalovirus infection in the first trimester of pregnancy: a multicentre observational study in the area of Barcelona) project recruitment flowchart.
See this image and copyright information in PMC

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