Exploratory Study: COVID-19 and Pregnancy

NCT ID: NCT04647994

Last Updated: 2022-06-09

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-11

Study Completion Date

2022-06-13

Brief Summary

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The SARS-CoV-2 infection may behave differently in pregnant and postpartum women in the short and long term. Several risk factors or medication use can interfere on disease' evolution and vertical transmission. Thus, due the current pandemic and the scarcity of scientific studies involving pregnant women with covid-19 or positive serology, combined with the need to elucidate the behavior of this viral infection in pregnant women in our population, this study aims to evaluate the clinical and laboratory evolution, transplacental passage, gestational and neonatal outcomes in pregnancies with positive SARS-CoV-2.

Detailed Description

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Conditions

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Pregnant Women Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Covid-19 HC patients

Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP.

SARS-CoV-2 serology

Intervention Type DIAGNOSTIC_TEST

Serology test of SARS-CoV-2 for pregnant women

Delivery patients

Asymptomatic pregnant women that tested SARS-CoV-2 serology (positive or negative serology) at the delivery time at Universitarian Hospital HU-USP and HC-FMUSP.

SARS-CoV-2 serology

Intervention Type DIAGNOSTIC_TEST

Serology test of SARS-CoV-2 for pregnant women

Prenatal patients

Pregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2.

SARS-CoV-2 serology

Intervention Type DIAGNOSTIC_TEST

Serology test of SARS-CoV-2 for pregnant women

Negative serology patients

Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2.

SARS-CoV-2 serology

Intervention Type DIAGNOSTIC_TEST

Serology test of SARS-CoV-2 for pregnant women

Interventions

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SARS-CoV-2 serology

Serology test of SARS-CoV-2 for pregnant women

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized or in delivery time;
* Asymptomatic pregnant women for SARS-CoV-2 during pregnancy and hospitalized for delivery at HU-USP.
* Pregnant women diagnosed with SARS-CoV-2 prior to delivery and who, after the quarantine period, followed prenatal care and delivered at the HU-USP or HCFMUSP.

Exclusion Criteria

* Non-confirmation of maternal SARS-CoV-2 infection in pregnant women hospitalized or in delivery time.
* Withdrawal of pregnant woman to continue in the study.
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rossana P Francisco, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina da Universidade de São Paulo - FMUSP

Locations

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Rossana P Fracisco

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rossana P Francisco, PhD

Role: CONTACT

+551126616209

Ana Claudia S Farche, PhD

Role: CONTACT

+551126619280

Facility Contacts

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Rossana P Francisco, PhD

Role: primary

+551126616209

Ana CS Farche, PhD

Role: backup

+551126619280

Other Identifiers

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30270820.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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