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

Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a prospective study that will enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies will cross over to the exposed cohort. Outcomes will be compared between the two cohorts.
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Unexposed (SARS-CoV-2 negative) cohort 		Women who do not experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.
  • 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.
Active Comparator
Exposed (SARS-CoV-2 positive) cohort 		Women who experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04718220
Status
Completed
Sponsor
Washington University School of Medicine

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 are to: (a) evaluate the full impact of SARS-CoV-2 in pregnancy to inform testing strategies, (b) examine the factors that impede testing during pregnancy, and (c) use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy and prenatal care during the pandemic. Investigators will prospectively enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies will cross over to the exposed cohort. In Aim 1, investigators will evaluate patients' and providers' perceptions of SARS-CoV-2 testing during pregnancy and the influence of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured interviews. In Aim 2, investigators will determine the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic and asymptomatic disease. It is hypothesized that SARS-CoV-2 infection will increase the risk of preterm birth by 12%. In Aim 3, investigators will estimate the risk of mother-to-fetus SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic fluid by assaying for viral RNA in the neonate, cord blood, and placenta. Collectively, Aims 1-3 will be interpreted by investigators, the Scientific Advisory Board and the Community Advisory Board who will apply data to devising targeted implementation strategies designed for rapid community dissemination to improve testing and prenatal care.