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Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment

Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06362486
Enrollment
1000
Registered
2024-04-12
Start date
2021-08-01
Completion date
2024-08-01
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19 and Pregnancy

Brief summary

The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose. Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months? Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS.

Interventions

OTHERSeverity of infection, time of infection.

Severity of infection, time of infection.

OTHERMental health assessment

Mental health assessment

Prognostic immunologic factors associated with cognitive impairment in children born of sars-cov-2-infected mothers.

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 1\. over 18 years old * 2\. Ultrasound-confirmed pregnancy * 3\. infected (past or present) or non-infected with Covid19

Exclusion criteria

* 1\. presents alcohol abuse during pregnancy * 2\. other concomitant causes of risk of demonstrated neurodevelopmental disorders * 3\. presents drug abuse except tobacco during pregnancy * 4\. under 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newbornbirth, at 6 months and 12 monthsexplore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026