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NCT Number: NCT05197621

The Impact of COVID-19 on Maternal and Neonatal Outcomes

The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection.

The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.

Recruiting

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Complications Pregnancy Complications, Infectious Pregnancy; Infection RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Virus Diseases

Age range

14 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Andrea Cox, MD, PhD

SUB_INVESTIGATOR

Andrew Pekosz, PhD

SUB_INVESTIGATOR

Heba Mostafa, PhD

SUB_INVESTIGATOR

Kimberly Jones-Beatty, DNP, CNM

CONTACT

[email protected]

Sabra Klein, PhD

SUB_INVESTIGATOR

William C Golden, M.D..

CONTACT

[email protected]

410-955-4588

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Vaccine Arm:

  • All pregnant women receiving their prenatal care from the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and/or a third dose booster during their pregnancy.

Exclusion criteria

  • Prior COVID-19 infection.

Inclusion criteria

for Sample Collection Arm:

  • All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center for delivery and their newborn (at birth), will be considered for enrollment.
  • Pregnant patients with a positive COVID-19 test during their pregnancy or at the time of admission to Labor & Delivery.

Exclusion criteria

  • None

Treatment and study plan

mRNA COVID-19 vaccine (Pfizer or Moderna)

Biological

mRNA vaccine received at any time during pregnancy course

Other names: Pfizer or Moderna COVID-19 vaccine

Primary outcomes

  1. Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy

    Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection

    Evaluation of biospecimens (maternal & neonatal blood, cord blood, placenta samples, neonatal stool samples & breast milk) collected from recently delivered pregnant women and neonates for biomarkers of placental inflammation and early onset neonatal sepsis.

Secondary outcomes

  1. To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people

    Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection

    Investigation of antibody responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations).

  2. To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people

    Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection

    Identification of T cell responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations).

  3. To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people

    Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection

    Determination of SARS-CoV-2 vaccine efficacy and characterization of breakthrough infections with SARS-CoV-2 variants that evaded vaccine induced immunity.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Jones-Beatty, DNP, CNM

CONTACT

[email protected]

William C Golden, MD

CONTACT

[email protected]

410-955-4588

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Integrated Research Center for Fetal Medicine

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jan 19, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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