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

Active, not recruiting

• Conditions: Covid19 and Pregnancy
• Interventions: Other: Mental health assessment; Other: biological; Other: Severity of infection, time of infection.

• Registration Number: NCT06362486
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2023-08-01
• Status Verified: 2024-02
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B N=500	Mental health assessment	Mental health assessment
Cohort C N=100	biological	biological
Cohort A N=1000	Severity of infection, time of infection.	neurodevelopment assessment by pediatrician, need to refer to neurodevelopmental assessment by specialized team. m-chat. autism diagnosis.

Primary Outcome Measures

Name	Time	Method
explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn	birth, at 6 months and 12 months	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.

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain