Status:

COMPLETED

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

Mercy Research

Conditions:

Covid19

Pregnancy Related

Eligibility:

FEMALE

Phase:

NA

Brief Summary

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the fact...

Detailed Description

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk of preterm birth, cesarean section, and maternal intensive care. The objectives of this study...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for exposed (SARS-CoV-2 positive) cohort:
  • Viable intrauterine pregnancy
  • Seroconversion or SARS-CoV-2 IgG antibodies or positive RT-PCR for SARS-CoV-2 during current pregnancy
  • Exclusion Criteria for exposed (SARS-CoV-2 positive) cohort:
  • No viable intrauterine pregnancy
  • No history of SARS-CoV-2 infection during pregnancy
  • Inclusion Criteria for unexposed (SARS-CoV-2 negative) cohort:
  • Viable intrauterine pregnancy
  • No history of SARS-CoV-2 infection prior to pregnancy
  • Exclusion Criteria for unexposed (SARS-CoV-2 negative) cohort:
  • No viable intrauterine pregnancy
  • Detection of SARS-CoV-2 IgG antibodies at enrollment

Exclusion

    Key Trial Info

    Start Date :

    March 1 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 30 2022

    Estimated Enrollment :

    448 Patients enrolled

    Trial Details

    Trial ID

    NCT04718220

    Start Date

    March 1 2021

    End Date

    November 30 2022

    Last Update

    April 3 2025

    Active Locations (1)

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    1

    Washington University Medical Center

    St Louis, Missouri, United States, 63110