Evaluating the effects of COVID-19 on pregnancy and newborns
The Impact of COVID-19 on Maternal and Neonatal Outcomes
This study looks at how COVID-19 and its vaccines affect pregnant women and their newborns to better understand the risks and outcomes during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years to 55 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05197621 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of COVID-19 infection on maternal and neonatal outcomes. It focuses on pregnant women receiving prenatal care at Johns Hopkins Hospital and those admitted for delivery, particularly examining the effects of mRNA COVID-19 vaccines on their immune responses. The study will also explore adverse outcomes related to COVID-19 during pregnancy and its implications for newborns. By analyzing these factors, the research seeks to fill knowledge gaps regarding COVID-19's effects on pregnancy and lactation.
Who should consider this trial
Good fit: Ideal candidates include pregnant women receiving prenatal care at Johns Hopkins Hospital who plan to receive an mRNA COVID-19 vaccine.
Not a fit: Patients who have previously been infected with COVID-19 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights that inform guidelines for COVID-19 vaccination in pregnant women, ultimately improving maternal and neonatal health outcomes.
How similar studies have performed: While there have been studies on COVID-19's impact on pregnancy, this specific approach focusing on mRNA vaccine responses in pregnant women is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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-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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: William C Golden, MD — Johns Hopkins University
- Study coordinator: William C Golden, MD
- Email: cgolden@jhmi.edu
- Phone: 410-955-4588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.