Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy

NCT ID: NCT04402918

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-17

Study Completion Date

2021-08-02

Brief Summary

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The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.

Detailed Description

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Conditions

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Sars-CoV2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pregnancy patients diagnosed with SARS Cov2 during pregnancy

Delivery day biological samples from the mother and the newborn will be performed

Group Type OTHER

biological samples day of delivery

Intervention Type DIAGNOSTIC_TEST

mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration

Interventions

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biological samples day of delivery

mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* pregnant woman
* diagnosed with Sars Cov-2 during pregnancy
* singleton or twin pregnancy
* informed consent

Exclusion Criteria

* virological or serological samples not done the day of delivery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Besancon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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2020/500

Identifier Type: -

Identifier Source: org_study_id

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