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

October 22, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Obdulia Alejos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2020

Primary Completion (Anticipated)

January 8, 2022

Study Completion (Anticipated)

January 23, 2022

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-COV-2020-59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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