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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Pregnancy Related

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women diagnosed with SARS-CoV-2<br>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 18months in which we would have an approximate total of 225pregnant 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 thosepregnant 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 of screening for perinatal infections | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal SARS-CoV-2 infection | Presence of SARS-CoV-2 in amniotic fluid or villichorionics from pregnant women with positive serology or PCR in nasopharyngeal aspirate duringgestation | 15 days |