The Impact of COVID-19 on Maternal and Neonatal Outcomes

May 6, 2026 updated by: Johns Hopkins University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sabra Klein, PhD
        • Sub-Investigator:
          • Andrew Pekosz, PhD
        • Sub-Investigator:
          • Andrea Cox, MD, PhD
        • Sub-Investigator:
          • Heba Mostafa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All pregnant women, aged 14-55, receiving prenatal care from 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, or, patients who have had a positive COVID-19 test during their pregnancy or at the time of admission to Labor & Delivery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccine Arm
Pregnant women who are planning to receive an mRNA COVID vaccine (Pfizer of Moderna), and/or a third booster vaccine, who consent to maternal blood collection before receipt of the vaccine and at 6 time points after receiving the vaccine and/or booster.
Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)
mRNA vaccine received at any time during pregnancy course
Other Names:
  • Pfizer or Moderna COVID-19 vaccine
Sample Collection at Delivery Arm
Pregnant patients who have tested positive for COVID during their pregnancy or have a positive COVID test at the time of admission to Labor & Delivery, who consent to collection of maternal blood, cord blood, placenta, and breast milk samples, as well as neonatal blood and stool samples. Patients testing negative for COVID at the time of admission to Labor & Delivery can be enrolled in the study as controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Testing will be performed from the time of study enrollment up to one year after sample collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Testing will be performed from the time of study enrollment up to one year after sample collection
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).
Testing will be performed from the time of study enrollment up to one year after sample collection
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.
Testing will be performed from the time of study enrollment up to one year after sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Integrated Research Center for Fetal Medicine

Investigators

  • Principal Investigator: William C Golden, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2020

Primary Completion (Estimated)

May 5, 2027

Study Completion (Estimated)

May 5, 2028

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00246472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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