Clinical trial NCT06362486: Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment
Official title: Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19 and Pregnancy
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn
timeFrame: birth, at 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References: