Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540029
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

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.

Condition or disease Intervention/treatment
Prenatal Stress Other: Maternal stress

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Infants' target gene methylation status [ Time Frame: At birth ]
    Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4


Other Outcome Measures:
  1. Maternal target gene methylation status [ Time Frame: At delivery ]
    Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4

  2. 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.

  3. Maternal sensitivity [ Time Frame: At 12 months of infants' age ]
    Maternal sensitivity measured by behavioral codings of mother-infant videorecorded interactions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Italy
IRCCS Mondino Foundation Recruiting
Pavia, PV, Italy, 27100
Contact: Cinzia Fattore    +39-0382-380385    cinzia.fattore@mondino.it   
Principal Investigator: Livio Provenzi, PhD         
Sub-Investigator: Serena Grumi, PhD         
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Layout table for additonal information
Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04540029    
Other Study ID Numbers: MOM-COPE
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
COVID-19
Epigenetics
Prenatal stress
Stress regulation
Maternal sensitivity
Pandemics
Serotonin transporter
Glucocorticoid receptor
Oxytocin receptor
Brain-derived neutropic factor