Prenatal StressMOM-COPENCT04540029
Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure
An observational study of Prenatal Stress, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 0 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Prenatal Stress
- What is being tested?
- Maternal stress
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2020to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- Single-parent mothers
- Medically assisted conception
- Infants' genetic or metabolic comorbidities
- Perinatal injuries or sensorial deficits
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Maternal stress
- Keywords
- COVID-19, Epigenetics, Prenatal stress, Stress regulation, Maternal sensitivity, Pandemics, Serotonin transporter, Glucocorticoid receptor, Oxytocin receptor, Brain-derived neutropic factor
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal stressOther
Prenatal COVID-19-related stress retrospectively self-reported by mothers after delivery.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Exposed Pregnancy (CEP) | Women who were pregnant and delivered during the outbreak of COVID-19 pandemic in Italy, and their infants. Receives: Other: Maternal stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months of infants' age
Secondary outcomes (1)
Infants' target gene methylation status
Methylation status of the following target genes: BDNF, FKBP5, NR3C1, OXTR, SLC6A4
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start6 May 2020
- Primary completion30 Apr 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Livio Provenzi, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540029
- Sponsor's protocol ID
- MOM-COPE
- Acronym
- MOM-COPE
- Status last verified
- May 2024
- First submitted
- 2 Sep 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33384402
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure
- ClinicalTrials.gov ID
- NCT04540029
- Acronym / sponsor ID
- MOM-COPE / MOM-COPE
- Conditions
- Prenatal Stress
- Keywords
- COVID-19, Epigenetics, Prenatal stress, Stress regulation, Maternal sensitivity, Pandemics, Serotonin transporter, Glucocorticoid receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Exposed Pregnancy (CEP) | – | Other: Maternal stressWomen who were pregnant and delivered during the outbreak of COVID-19 pandemic in Italy, and their infants. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Single-parent mothers
- Medically assisted conception
- Infants' genetic or metabolic comorbidities
- Perinatal injuries or sensorial deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal stressPrenatal COVID-19-related stress retrospectively self-reported by mothers after delivery. | Other | COVID-19 Exposed Pregnancy (CEP) |
Primary outcome
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.
1 secondary outcome
Infants' target gene methylation status
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 33384402Provenzi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livio Provenzi, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prenatal Stress, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant negative emotionality (time frame: At 12 months of infants' age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.