NCT04647994

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

2.1 years

First QC Date

November 23, 2020

Last Update Submit

June 7, 2022

Conditions

Pregnant WomenCovid19

Keywords

pregnancySARS-CoV-2vertical transmission

Outcome Measures

Primary Outcomes (1)

  • Diagnostic test: SARS-CoV-2 serology

    Number of pregnant women with COVID-19 infection assessed with a serology test

    01/07/2021

Secondary Outcomes (23)

  • Laboratorial analysis of maternal and umbilical cord blood

    01/07/2021

  • Laboratorial analysis of Amniotic Fluid

    01/07/2021

  • Placenta biopsy

    01/07/2021

  • Laboratorial analysis of colostrum

    01/07/2021

  • Ovarian remains biopsy

    01/07/2021

  • +18 more secondary outcomes

Study Arms (4)

Covid-19 HC patients

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

Diagnostic Test: SARS-CoV-2 serology

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.

Diagnostic Test: SARS-CoV-2 serology

Prenatal patients

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

Diagnostic Test: SARS-CoV-2 serology

Negative serology patients

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

Diagnostic Test: SARS-CoV-2 serology

Interventions

SARS-CoV-2 serologyDIAGNOSTIC_TEST

Serology test of SARS-CoV-2 for pregnant women

Covid-19 HC patientsDelivery patientsNegative serology patientsPrenatal patients

Eligibility Criteria

Age17 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized, in prenatal care, or in delivery time.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rossana P Fracisco

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rossana P Francisco, PhD

    Faculdade de Medicina da Universidade de São Paulo - FMUSP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rossana P Francisco, PhD

CONTACT

+551126616209rossana.francisco@hc.fm.usp.br

Ana Claudia S Farche, PhD

CONTACT

+551126619280anafarche@usp.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

April 11, 2020

Primary Completion

June 1, 2022

Study Completion

June 13, 2022

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations

BR(1)