Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure

Prenatal Stress Clinical Trial

— MOM-COPE  

Official title:

Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540029
• Other study ID #: MOM-COPE
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2024
• Source: IRCCS National Neurological Institute "C. Mondino" Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 15, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Single-parent mothers

• Medically assisted conception

• Infants' genetic or metabolic comorbidities

• Perinatal injuries or sensorial deficits

Related Conditions & MeSH terms

• COVID-19
• Prenatal Stress

Intervention

Other:
• Maternal stress
Prenatal COVID-19-related stress retrospectively self-reported by mothers after delivery.

Locations

Country	Name	City	State
Italy	IRCCS Mondino Foundation	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal target gene methylation status	Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4	At delivery
Other	Maternal mental health	Measure of maternal mental health obtained through the State dimension of the Stait-Trait Anxiety Inventory. The score ranges from 20 to 80, with a clinical cut-off set at 40. Higher scores reflect higher anxiety.	At 3, 6, and 12 months of infants' age
Other	Maternal sensitivity	Maternal sensitivity measured by behavioral codings of mother-infant videorecorded interactions	At 12 months of infants' age
Primary	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	Infants' target gene methylation status	Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4	At birth