1. Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE): study protocol for a multicentric longitudinal project
- Author
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Marco Zecca, Barbara Gardella, Elena Grossi, Roberto Giorda, Elisa Fazzi, Simona Orcesi, Anna Cavallini, Livio Provenzi, Renato Borgatti, Pierangelo Veggiotti, Serena Grumi, Giacomo Biasucci, Renza Bonini, Lidia Decembrino, Bruno Drera, Rossana Falcone, Roberta Giacchero, Renata Nacinovich, Camilla Pisoni, Federico Prefumo, Barbara Scelsa, Maria Valentina Spartà, Patrizia Accorsi, Rossana Bucci, Elisa Cavalleri, Laura Malerba, Paola Martelli, Mario Motta, Sonia Zatti, Emanuela Bertazzoli, Giovanna Centinaio, Maria Roberta Longo, Benedetta Chiara Pietra, Caterina Sabatini, Alberto Chiara, Giuliana Del Campo, Luisa Magnani, Dario Pantaleo, Arsenio Spinillo, Giulia Bensi, Cristiana Pavesi, Daniela Russo, Gaia Kullmann, Provenzi, L, Grumi, S, Giorda, R, Biasucci, G, Bonini, R, Cavallini, A, Decembrino, L, Drera, B, Falcone, R, Fazzi, E, Gardella, B, Giacchero, R, Nacinovich, R, Pisoni, C, Prefumo, F, Scelsa, B, Spartà, M, Veggiotti, P, Orcesi, S, and Borgatti, R
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Research design ,Adult ,Coronavirus disease 2019 (COVID-19) ,Mothers ,perinatology ,Child Development ,Pregnancy ,Outcome Assessment, Health Care ,Medicine ,Humans ,Multicenter Studies as Topic ,Longitudinal Studies ,Socioemotional selectivity theory ,business.industry ,SARS-CoV-2 ,COVID-19 ,Infant ,Paediatrics ,General Medicine ,DNA Methylation ,medicine.disease ,Mental health ,Pregnancy Complications ,Maternal sensitivity ,Prenatal stress ,Italy ,MED/39 - NEUROPSICHIATRIA INFANTILE ,Maternal Exposure ,Research Design ,Cohort ,Maternal-Fetal Relations ,Female ,business ,mental health ,Stress, Psychological ,Clinical psychology - Abstract
IntroductionCOVID-19 is a highly infectious respiratory disease that rapidly emerged as an unprecedented epidemic in Europe, with a primary hotspot in Northern Italy during the first months of 2020. Its high infection rate and rapid spread contribute to set the risk for relevant psychological stress in citizens. In this context, mother–infant health is at risk not only because of potential direct exposure to the virus but also due to high levels of stress experienced by mothers from conception to delivery. Prenatal stress exposure associates with less-than-optimal child developmental outcomes, and specific epigenetic mechanisms (eg, DNA methylation) may play a critical role in mediating this programming association.Methods and analysisWe present the methodological protocol for a longitudinal, multicentric study on the behavioural and epigenetic effects of COVID-19-related prenatal stress in a cohort of mother–infant dyads in Northern Italy. The dyads will be enrolled at 10 facilities in Northern Italy. Saliva samples will be collected at birth to assess the methylation status of specific genes linked with stress regulation in mothers and newborns. Mothers will provide retrospective data on COVID-19-related stress during pregnancy. At 3, 6 and 12 months, mothers will provide data on child behavioural and socioemotional outcomes, their own psychological status (stress, depressive and anxious symptoms) and coping strategies. At 12 months, infants and mothers will be videotaped during semistructured interaction to assess maternal sensitivity and infant’s relational functioning.Ethics and disseminationThis study was approved by the Ethics Committee (Pavia). Results will be published in peer-reviewed journals and presented at national and international scientific conferences.Trial registration numberNCT04540029; Pre-results.
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- 2020