Studying COVID-19 Effects on Pregnant Women and Babies
The Impact of COVID-19 on Maternal and Neonatal Outcomes
Recruiting
Observational Study
COVID-19Pregnancy; Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 55
Sex
Female
Study type
Observational
Participants needed
300 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for pregnant women who get their prenatal care at specific hospitals, as well as those who are delivering their babies there. Participants will help researchers learn more about the effects of COVID-19 on pregnancy and newborns.
Are You a Good Fit for This Trial?
You may be able to join if
I am a pregnant woman receiving prenatal care at the designated hospitals.
I plan to receive an mRNA COVID vaccine or a booster during my pregnancy.
I am a pregnant woman admitted for delivery at the designated hospitals.
I have tested positive for COVID-19 during my pregnancy or at delivery.
You may not be able to join if
I have had a prior COVID-19 infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 ribonucl…
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.
Trial Locations
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Eligibility Criteria
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-1…
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
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