Prenatal Stress
Conditions
Keywords
COVID-19, Epigenetics, Prenatal stress, Stress regulation, Maternal sensitivity, Pandemics, Serotonin transporter, Glucocorticoid receptor, Oxytocin receptor, Brain-derived neutropic factor
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.
Interventions
OTHERMaternal stress
Prenatal COVID-19-related stress retrospectively self-reported by mothers after delivery.
Sponsors
IRCCS National Neurological Institute C. Mondino Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant negative emotionality | At 12 months of infants' age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infants' target gene methylation status | At birth | Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal target gene methylation status | At delivery | Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4 |
| Maternal mental health | At 3, 6, and 12 months of infants' age | 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. |
| Maternal sensitivity | At 12 months of infants' age | Maternal sensitivity measured by behavioral codings of mother-infant videorecorded interactions |
Countries
Italy
Outcome results
None listed