Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure (MOM-COPE)
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|ClinicalTrials.gov Identifier: NCT04540029|
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment|
|Prenatal Stress||Other: Maternal stress|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure|
|Actual Study Start Date :||May 6, 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||May 31, 2023|
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
Prenatal COVID-19-related stress retrospectively self-reported by mothers after delivery.
Non-Exposed Pregnancy (NEP)
Women who were pregnant and delivered during an anticipated COVID-19 free period in Italy, and their infants.
- Infant negative emotionality [ Time Frame: 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.
- Infants' target gene methylation status [ Time Frame: At birth ]Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4
- Maternal target gene methylation status [ Time Frame: At delivery ]Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4
- Maternal mental health [ Time Frame: 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 [ Time Frame: At 12 months of infants' age ]Maternal sensitivity measured by behavioral codings of mother-infant videorecorded interactions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540029
|IRCCS Mondino Foundation||Recruiting|
|Pavia, PV, Italy, 27100|
|Contact: Cinzia Fattore +39-0382-380385 email@example.com|
|Principal Investigator: Livio Provenzi, PhD|
|Sub-Investigator: Serena Grumi, PhD|