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

doi:10.1136/bmjopen-2020-044585

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

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	e044585
Journal	BMJ Open
Volume	10
Issue number	12
DOIs	https://doi.org/10.1136/bmjopen-2020-044585
Publication status	Published - Dec 31 2020

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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. V., Veggiotti, P., Orcesi, S., & Borgatti, R. (2020). Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE): study protocol for a multicentric longitudinal project. BMJ Open, 10(12), e044585. https://doi.org/10.1136/bmjopen-2020-044585

Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE) : study protocol for a multicentric longitudinal project. / Provenzi, Livio; Grumi, Serena; Giorda, Roberto; Biasucci, Giacomo; Bonini, Renza; Cavallini, Anna; Decembrino, Lidia; Drera, Bruno; Falcone, Rossana; Fazzi, Elisa; Gardella, Barbara; Giacchero, Roberta; Nacinovich, Renata; Pisoni, Camilla; Prefumo, Federico; Scelsa, Barbara; Spartà, Maria Valentina; Veggiotti, Pierangelo; Orcesi, Simona ; Borgatti, Renato.

In: BMJ Open, Vol. 10, No. 12, 31.12.2020, p. e044585.

Research output: Contribution to journal › Article › peer-review

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, MV, Veggiotti, P, Orcesi, S & Borgatti, R 2020, 'Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE): study protocol for a multicentric longitudinal project', BMJ Open, vol. 10, no. 12, pp. e044585. https://doi.org/10.1136/bmjopen-2020-044585

Provenzi, Livio ; Grumi, Serena ; Giorda, Roberto ; Biasucci, Giacomo ; Bonini, Renza ; Cavallini, Anna ; Decembrino, Lidia ; Drera, Bruno ; Falcone, Rossana ; Fazzi, Elisa ; Gardella, Barbara ; Giacchero, Roberta ; Nacinovich, Renata ; Pisoni, Camilla ; Prefumo, Federico ; Scelsa, Barbara ; Spartà, Maria Valentina ; Veggiotti, Pierangelo ; Orcesi, Simona ; Borgatti, Renato. / Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE) : study protocol for a multicentric longitudinal project. In: BMJ Open. 2020 ; Vol. 10, No. 12. pp. e044585.

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

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.",

author = "Livio Provenzi and Serena Grumi and Roberto Giorda and Giacomo Biasucci and Renza Bonini and Anna Cavallini and Lidia Decembrino and Bruno Drera and Rossana Falcone and Elisa Fazzi and Barbara Gardella and Roberta Giacchero and Renata Nacinovich and Camilla Pisoni and Federico Prefumo and Barbara Scelsa and Spart{\`a}, {Maria Valentina} and Pierangelo Veggiotti and Simona Orcesi and Renato Borgatti",

note = "{\textcopyright} 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.",

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doi = "10.1136/bmjopen-2020-044585",

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T1 - Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE)

T2 - study protocol for a multicentric longitudinal project

AU - Provenzi, Livio

AU - Grumi, Serena

AU - Giorda, Roberto

AU - Biasucci, Giacomo

AU - Bonini, Renza

AU - Cavallini, Anna

AU - Decembrino, Lidia

AU - Drera, Bruno

AU - Falcone, Rossana

AU - Fazzi, Elisa

AU - Gardella, Barbara

AU - Giacchero, Roberta

AU - Nacinovich, Renata

AU - Pisoni, Camilla

AU - Prefumo, Federico

AU - Scelsa, Barbara

AU - Spartà, Maria Valentina

AU - Veggiotti, Pierangelo

AU - Orcesi, Simona

AU - Borgatti, Renato

PY - 2020/12/31

Y1 - 2020/12/31

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2020-044585

DO - 10.1136/bmjopen-2020-044585

M3 - Article

C2 - 33384402

VL - 10

SP - e044585

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 12

ER -

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

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