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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598347
• Other study ID #: IIBSP-COV-2020-59
• Status: Recruiting
• Start date: August 8, 2020
• Est. completion date: January 23, 2022

Study information

• Verified date: October 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Obdulia Alejos Abad, PhD, MD
• Phone: +34935537041
• Email: oalejos[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: January 23, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pregnancy Related

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (25)

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Della Gatta AN, Rizzo R, Pilu G, Simonazzi G. Coronavirus disease 2019 during pregnancy: a systematic review of reported cases. Am J Obstet Gynecol. 2020 Jul;223(1):36-41. doi: 10.1016/j.ajog.2020.04.013. Epub 2020 Apr 18. — View Citation

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Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621. — View Citation

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Karami P, Naghavi M, Feyzi A, Aghamohammadi M, Novin MS, Mobaien A, Qorbanisani M, Karami A, Norooznezhad AH. WITHDRAWN: Mortality of a pregnant patient diagnosed with COVID-19: A case report with clinical, radiological, and histopathological findings. Travel Med Infect Dis. 2020 Apr 11:101665. doi: 10.1016/j.tmaid.2020.101665. [Epub ahead of print] — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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