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Evaluation 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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04598347
Enrollment
225
Registered
2020-10-22
Start date
2020-08-08
Completion date
2022-01-23
Last updated
2020-10-26

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

Conditions

Covid19, Pregnancy Related

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.

Interventions

None listed

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perinatal SARS-CoV-2 infection15 daysPresence of SARS-CoV-2 in amniotic fluid or villichorionics from pregnant women with positive serology or PCR in nasopharyngeal aspirate duringgestation

Countries

Spain

Contacts

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

Outcome results

None listed

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