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Active, not recruitingNCT06362486Updated Apr 12, 2024

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

An observational study in Covid19 and Pregnancy, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Active, not recruiting at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Covid19 and Pregnancy

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

pregnant women over 18 years of age, without concomitant diseases that affect the neurodevelopment of the newborn or use of toxic substances. For the data collection of the CASE group, these women must have been or be positive for Covid-19. For the CONTROL group, the pregnant woman must not have been infected by Covid-19.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    1. presents alcohol abuse during pregnancy
    1. other concomitant causes of risk of demonstrated neurodevelopmental disorders
    1. presents drug abuse except tobacco during pregnancy
    1. under 18 years of age
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cohort A N=1000

    neurodevelopment assessment by pediatrician, need to refer to neurodevelopmental assessment by specialized team. m-chat. autism diagnosis.

    Other: Severity of infection, time of infection.

  • Cohort B N=500

    Mental health assessment

    Other: Mental health assessment

  • Cohort C N=100

    biological

    Other: biological

Interventions

  • OtherSeverity of infection, time of infection.

    Severity of infection, time of infection.

  • OtherMental health assessment

    Mental health assessment

  • Otherbiological

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

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What researchers measure

Primary outcomes

  1. explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn

    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.

    Time frame: birth, at 6 months and 12 months

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Study locations

1 site
  • Hospital Universitario Virgen del Rocío
    Sevilla, 41013, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06362486
Lead sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
Aug 1, 2021
Primary completion
Aug 1, 2023
Completion
Aug 1, 2024 (estimated)
Last update
Apr 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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