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

NCT04718220 | Completed DMC

• 1 other identifier: 202012075
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

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 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

Keywords

pregnancy; COVID-19; SARS-CoV-2; antibody testing; pregnancy complication; maternal complication; neonatal complication; mother-to-fetal transmission; placental pathology; prenatal; stress; SARS-CoV-2 testing; social determinants of health

Outcome Measures

Primary Outcomes (1)

• Rate of preterm delivery

  Childbirth prior to 37 weeks of pregnancy, to be determined in accordance to standard pregnancy dating and the established estimated due date.

  20 weeks gestation until childbirth

Secondary Outcomes (18)

• Rate of preeclampsia

  After 20 weeks gestation and up to 6 weeks postpartum

• Rate of gestational hypertension

  After 20 weeks gestation and up to 6 weeks postpartum

• Rate of cesarean section

  Time of delivery

• Rate of stillbirth

  Between 20 weeks gestation and childbirth

• Rate of fetal growth restriction

  Between conception and childbirth

Study Arms (2)

Unexposed (SARS-CoV-2 negative) cohort

PLACEBO COMPARATOR

Women who do not experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.

Diagnostic Test: Antibody testing for SARS-CoV-2 IgG

Exposed (SARS-CoV-2 positive) cohort

ACTIVE COMPARATOR

Women who experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.

Diagnostic Test: Testing for SARS-CoV-2 RNA; Diagnostic Test: Testing for SARS-CoV-2 IgM/IgG

Interventions

Antibody testing for SARS-CoV-2 IgG DIAGNOSTIC_TEST

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.

Unexposed (SARS-CoV-2 negative) cohort

Testing for SARS-CoV-2 RNA DIAGNOSTIC_TEST

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.

Exposed (SARS-CoV-2 positive) cohort

Testing for SARS-CoV-2 IgM/IgG DIAGNOSTIC_TEST

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.

Exposed (SARS-CoV-2 positive) cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Viable intrauterine pregnancy
• Seroconversion or SARS-CoV-2 IgG antibodies or positive RT-PCR for SARS-CoV-2 during current pregnancy

You may not qualify if:

• No viable intrauterine pregnancy
• No history of SARS-CoV-2 infection during pregnancy
• Viable intrauterine pregnancy
• No history of SARS-CoV-2 infection prior to pregnancy
• No viable intrauterine pregnancy
• Detection of SARS-CoV-2 IgG antibodies at enrollment

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Mercy Research: collaborator

Study Sites (1)

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Premature Birth; Pregnancy Complications

Interventions

Antibody Formation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunity, Active; Adaptive Immunity; Immunity; Immune System Phenomena

Study Officials

• Megan E Foeller, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: September 9, 2022
• Study Completion: November 30, 2022
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)