Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE): study protocol for a multicentric longitudinal project

Livio Provenzi, Serena Grumi, Roberto Giorda, Giacomo Biasucci, Renza Bonini, Anna Cavallini, Lidia Decembrino, Bruno Drera, Rossana Falcone, Elisa Fazzi, Barbara Gardella, Roberta Giacchero, Renata Nacinovich, Camilla Pisoni, Federico Prefumo, Barbara Scelsa, Maria Valentina Spartà, Pierangelo Veggiotti, Simona Orcesi, Renato Borgatti, MOM-COPE Study Group, 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, Marco Zecca, Giulia Bensi, Elena Grossi, Cristiana Pavesi, Daniela Russo, Gaia Kullmann, Livio Provenzi, Serena Grumi, Roberto Giorda, Giacomo Biasucci, Renza Bonini, Anna Cavallini, Lidia Decembrino, Bruno Drera, Rossana Falcone, Elisa Fazzi, Barbara Gardella, Roberta Giacchero, Renata Nacinovich, Camilla Pisoni, Federico Prefumo, Barbara Scelsa, Maria Valentina Spartà, Pierangelo Veggiotti, Simona Orcesi, Renato Borgatti, MOM-COPE Study Group, 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, Marco Zecca, Giulia Bensi, Elena Grossi, Cristiana Pavesi, Daniela Russo, Gaia Kullmann

Abstract

Introduction: COVID-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 analysis: We 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 dissemination: This 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 number: NCT04540029; Pre-results.

Keywords: COVID-19; mental health; perinatology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Overview of the specific aims of the MOM-COPE (Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure) study.
Figure 2
Figure 2
Distribution of the neonatal units participating to the MOM-COPE (Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure) project in the geographical area of Northern Italy. Authors’ own work. Original drawing by Marina Barello.
Figure 3
Figure 3
Schematic overview of the assessments included in the study design. Enrolment for wave 1 (COVID-exposure pregnancy, CEP) is planned from May to November 2020; enrolment for wave 2 (non-exposure pregnancy, NEP) is planned from May to November 2021. IBQ-R, Infant Behavior Questionnaire—Revised; MCPS, Maternal COVID-19-related Prenatal Stress.
Figure 4
Figure 4
Schematic summary of the target genes’ regions of interest for the present study.

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