COVID-19NCT05197621
The Impact of COVID-19 on Maternal and Neonatal Outcomes
An observational study of COVID-19 and Pregnancy; Infection, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pregnancy; Infection
- What is being tested?
- mRNA COVID-19 vaccine (Pfizer or Moderna)
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2020to 5 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- Prior COVID-19 infection.
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kimberly Jones-Beatty, DNP, CNM contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
William C Golden, M.D.., 410-955-4588, cgolden@jhmi.edu
Kimberly Jones-Beatty, DNP, CNM, kjone111@jhmi.edu
About this study
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.
- Conditions
- COVID-19, Pregnancy; Infection
- Being tested
- mRNA COVID-19 vaccine (Pfizer or Moderna)
- Medical subject headings
- COVID-19, Pregnancy Complications, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA COVID-19 vaccine (Pfizer or Moderna)Biological
Also called Pfizer or Moderna COVID-19 vaccine
mRNA vaccine received at any time during pregnancy course
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: mRNA COVID-19 vaccine (Pfizer or Moderna) | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
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.
Measured: Testing will be performed from the time of study enrollment up to one year after sample collection
Secondary outcomes (3)
To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
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).
Measured: 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
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).
Measured: 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
Determination of SARS-CoV-2 vaccine efficacy and characterization of breakthrough infections with SARS-CoV-2 variants that evaded vaccine induced immunity.
Measured: Testing will be performed from the time of study enrollment up to one year after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start13 Apr 2020
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated Research Center for Fetal Medicine
- Responsible party
- Sponsor
- Investigators
- William C Golden, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197621
- Sponsor's protocol ID
- IRB00246472
- Status last verified
- May 2026
- First submitted
- 14 Jan 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19 on Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT05197621
- Acronym / sponsor ID
- IRB00246472
- Conditions
- COVID-19, Pregnancy; Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Integrated Research Center for Fetal Medicine
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Arm | – | Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)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. |
| 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. |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- Prior COVID-19 infection.
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA COVID-19 vaccine (Pfizer or Moderna)Also: Pfizer or Moderna COVID-19 vaccinemRNA vaccine received at any time during pregnancy course | Biological | Vaccine Arm |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Jones-Beatty, DNP, CNM contact
William C Golden, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pregnancy; Infection, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William C Golden, MD (410-955-4588, cgolden@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.