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
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ClinicalTrials.gov Identifier: NCT04598347 |
Recruitment Status : Unknown
Verified October 2020 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was: Recruiting
First Posted : October 22, 2020
Last Update Posted : October 26, 2020
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Condition or disease |
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Covid19 Pregnancy Related |
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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 225 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 18 Months |
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 |
Actual Study Start Date : | August 8, 2020 |
Estimated Primary Completion Date : | January 8, 2022 |
Estimated Study Completion Date : | January 23, 2022 |

Group/Cohort |
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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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- Perinatal SARS-CoV-2 infection [ Time Frame: 15 days ]Presence of SARS-CoV-2 in amniotic fluid or villichorionics from pregnant women with positive serology or PCR in nasopharyngeal aspirate duringgestation
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598347
Contact: Obdulia Alejos Abad, PhD, MD | +34935537041 | oalejos@santpau.cat |
Spain | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Obdulia Alejos, MD oalejos@santpau.cat | |
Principal Investigator: Obdulia Alejos, MD |
Responsible Party: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT04598347 |
Other Study ID Numbers: |
IIBSP-COV-2020-59 |
First Posted: | October 22, 2020 Key Record Dates |
Last Update Posted: | October 26, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |