Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure

NCT04540029 | Completed

• 1 other identifier: MOM-COPE
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The rapidly spreading coronavirus Covid-19 pandemic is a major concern worldwide and Italy is at the forefront of this emergency. At the present moment, the effects on the offspring of Covid-19 disease in pregnant women and/or the indirect effect of COVID-19-related prenatal maternal stress are poorly understood. Epigenetic mechanisms - and especially DNA methylation - are involved in the embedding of prenatal exposures to large-scale disasters into the epigenome and phenotypic outcomes of the offspring. Specific target genes include SLC6A4, NR3C1, OXTR, BDNF, and FKBP5. The central hypothesis of this project is that the exposure to the COVID-19-related prenatal maternal stress may affect infants' outcomes from birth to 12 months partially through increased methylation of target genes involved in stress regulation. The main goal is to investigate the association between Covid-19 disease in pregnancy or COVID-19-related PMS in women pregnant during the first 9 months of the year 2020 and the emotional, social, and cognitive developmental outcomes in their infants from birth to 12 months. Additionally, the role of target genes methylation in mediating this association will be investigated. Mothers and their infants will be enrolled from the delivery units of eleven neonatal facilities located in Northern Italy's COVID-19 contagion hotspot. One group will be enrolled from April to October 2020 (COVID-Exposure Pregnancy, CEP), a second group will be enrolled from April to October 2021 (Non-Exposure Pregnancy, NEP). Moreover, the CEP group will include mothers positive or exposed to COVID-19-related MPS during different trimesters of pregnancy, allowing within-group comparisons on developmentally sensitive time windows. Within 48 hours from baby delivery, saliva samples will be obtained from CEP and NEP newborns, immediately stored at -20°C and analyzed for epigenetic analyses using Next-Generation Sequencing. At 3 and 6 months, mothers will be asked to fill-in validated and reliable questionnaires on the emotional and social-behavioral development of their infants. At 12 months, infants' stress regulation and maternal sensitivity will be evaluated through video recording of mother-infant interactions. This study will provide unprecedented relevant insights on the biochemical mechanisms underlying the impact of Covid-19 disease and the related PMS on human offspring's developmental outcomes.

Conditions

Prenatal Stress

Keywords

COVID-19; Epigenetics; Prenatal stress; Stress regulation; Maternal sensitivity; Pandemics; Serotonin transporter; Glucocorticoid receptor; Oxytocin receptor; Brain-derived neutropic factor

Outcome Measures

Primary Outcomes (1)

• Infant negative emotionality

  Measure of infant Negative Emotionality through the Infant Behavior Questionnaire - Revised questionnaire. Negative Emotionality mean score ranges from 1 to 7 and higher scores reflect higher negative emotionality.

  At 12 months of infants' age

Secondary Outcomes (1)

• Infants' target gene methylation status

  At birth

Other Outcomes (3)

• Maternal target gene methylation status

  At delivery

• Maternal mental health

  At 3, 6, and 12 months of infants' age

• Maternal sensitivity

  At 12 months of infants' age

Study Arms (1)

COVID-19 Exposed Pregnancy (CEP)

Women who were pregnant and delivered during the outbreak of COVID-19 pandemic in Italy, and their infants.

Other: Maternal stress

Interventions

Maternal stress OTHER

Prenatal COVID-19-related stress retrospectively self-reported by mothers after delivery.

COVID-19 Exposed Pregnancy (CEP)

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Subjects will be mother-infant dyads as defined in the Eligibility Criteria section. Maternal age equal or greater than 18 years. Infants' will be enrolled at birth and followed-up to 12 month-age.

You may qualify if:

• Italian nationality or full mastery of Italian language to access on-line questionnaires without support
• No prenatal pathologies or perinatal risks
• Maternal age higher than 18 years
• Newborns' gestational age equal or higher than 37 weeks

You may not qualify if:

• Single-parent mothers
• Medically assisted conception
• Infants' genetic or metabolic comorbidities
• Perinatal injuries or sensorial deficits

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

IRCCS Mondino Foundation

Pavia, PV, 27100, Italy

Location

Related Publications (1)

• 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, Sparta MV, Veggiotti P, Orcesi S, Borgatti R; MOM-COPE Study Group. Measuring the Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE): study protocol for a multicentric longitudinal project. BMJ Open. 2020 Dec 31;10(12):e044585. doi: 10.1136/bmjopen-2020-044585.

  PMID: 33384402 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Livio Provenzi, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 7, 2020
• Study Start: May 6, 2020
• Primary Completion: April 30, 2023
• Study Completion: May 15, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)