Official Title
Valuation of the Possible Vertical Transmission of SARS-CoV-2 Through Study of Amniotic Fluid and Chorionic Villi of Affected Pregnant Women for the COVID-19
Brief Summary

Longitudinal prospective study in pregnant women withpositive serology or PCR for SARS-CoV-2 and indicationinvasive technique (amniocentesis or chorionic biopsy) that has the objective to evaluate the possible vertical transmission of SARS-CoV-2in the amniotic fluid or chorionic villi of pregnant women affected by coronavirus in the different periods of gestation.

Detailed Description

Patients will be recruited at the time theypresent an indication to perform a
techniqueinvasive (amniocentesis or chorion biopsy). Eitherscreening for first or second
trimester aneuploidies ofhigh risk, due to the presence of fetal malformation, due toearly
intrauterine growth retardation (ICR) or due tosuspected chorioamnionitis.

The study population will be pregnant women diagnosed with SARS-CoV-2 infection(by PCR on
nasopharyngeal aspirate or serology)that have an indication to perform an invasive
technique(chorionic biopsy or amniocentesis) along thegestation.The sample size will depend
on the duration of theSARS-CoV-2 pandemic.Initially we propose a study period of 18 months in
which we would have an approximate total of 225 pregnant women with indication of invasive
technique.It is planned to conduct a PCR study for SARS-CoV-2 in amniotic fluid or chorionic
villi to those pregnant women diagnosed with SARS-CoV-2 infection(approximately 5% of the
total pregnant womenwith indication of invasive technique (11-12 pregnant women)).This
determination is made as part of theroutine clinical practice in the context of the study
ofscreening for perinatal infections.

Unknown status
COVID19
Pregnancy Related
Eligibility Criteria

Inclusion Criteria:

- Pregnant women diagnosed with SARS-CoV-2 (by PCR in aspiratenasopharyngeal or
serologies)

- Patients indicated for an invasive technique(chorionic biopsy or amniocentesis

Exclusion Criteria:

- Patients who do not meet the inclusion criteria

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
Spain
Locations

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain

Investigator: Obdulia Alejos, MD
oalejos@santpau.cat

Investigator: Obdulia Alejos, MD

Contacts

Obdulia Alejos Abad, PhD, MD
+34935537041
oalejos@santpau.cat

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
NCT Number
MeSH Terms
COVID-19