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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women diagnosed with SARS-CoV-2 | 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 |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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regnant women diagnosed with SARS-CoV-2 (by PCR in aspiratenasopharyngeal or serologies) that indicate an invasive technique(chorionic biopsy or amniocentesis) throughout pregnancy either due to high riskof aneuploidies in the first or second trimester screening, due to the presence offetal malformation, due to diagnosis of early intrauterine growth retardation (ICR)or for suspected chorioamnionitis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Obdulia Alejos Abad, PhD, MD | Contact | +34935537041 | oalejos@santpau.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32091533 | Background | Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. | |
| 32292903 | Background |
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A specific database will be created for the study in which each patient will beAnonymously encoded in such a way that it is not identifiable.The person responsible for database creation, data entry and analysisstatistician will be Dra. Obdulia Alejos Abad.
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umbilical cord blood, samples from the neonatal nasopharynx, the amnio-chorion interface, and placental tissue
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| 32240123 | Background | CDC COVID-19 Response Team. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):382-386. doi: 10.15585/mmwr.mm6913e2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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