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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598347
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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.

Condition or disease
Covid19 Pregnancy Related

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.

Study Design
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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
Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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
umbilical cord blood, samples from the neonatal nasopharynx, the amnio-chorion interface, and placental tissue

Eligibility Criteria
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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
Study Population
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.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Obdulia Alejos Abad, PhD, MD +34935537041 oalejos@santpau.cat

Locations
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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         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Publications:

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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No