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Search / Trial NCT05197621

The Impact of COVID-19 on Maternal and Neonatal Outcomes

Launched by JOHNS HOPKINS UNIVERSITY · Jan 14, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how COVID-19 affects pregnant women and their newborns. Researchers want to learn more about the possible risks associated with COVID-19 during pregnancy and how it might impact both the mother and the baby. They are particularly interested in understanding how well COVID-19 vaccines work for pregnant women, since they were not included in the original vaccine trials.

To participate in this study, women must be pregnant and receiving prenatal care at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center. They should also be planning to receive an mRNA COVID vaccine, like those from Pfizer or Moderna, during their pregnancy. Additionally, women who test positive for COVID-19 while in the hospital for delivery, along with their newborns, may also be eligible for the study. Participants can expect to provide information about their health and may have samples collected to help researchers learn more about the immune responses to the vaccine and the virus during pregnancy. This research aims to provide important information that could help guide future vaccine recommendations for pregnant women.

Gender

FEMALE

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-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

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

William C Golden, MD

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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