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

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 factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.

Conditions

• Covid19
• Pregnancy Related
• Maternal Complication of Pregnancy
• Coronavirus
• Neonatal Infection
• Prenatal Stress
• Preterm Birth

Interventions

DIAGNOSTIC_TEST

Antibody testing for SARS-CoV-2 IgG

Women enrolled into the unexposed (SARS-CoV-2 negative) cohort will undergo testing for SARS-CoV-2 IgG antibodies at enrollment, every trimester of pregnancy, and during delivery hospitalization.

DIAGNOSTIC_TEST

Testing for SARS-CoV-2 RNA

Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of placental tissue, umbilical cord blood, amniotic tissue, and neonates for SARS-CoV-2 RNA, as available.

DIAGNOSTIC_TEST

Testing for SARS-CoV-2 IgM/IgG

Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of umbilical cord blood for SARS-CoV-2 IgG and IgM antibodies, as available.

Sponsors & Collaborators

• Mercy Research

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Megan E Foeller, MD · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-09-09

Completion

2022-11-30

Countries

• United States

Study Locations