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โ† Trials
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RSV Vaccine Pregnancy Registry

Recruitingn/aAges 18 Years - 50 YearsFemaleCorEvitas
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In plain words

What the trial is, and whether it could suit you

The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including: * Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolong

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals must meet the following inclusion criteria to be eligible for inclusion in the study: 1. A resident of the US at enrollment 2. 18 to 50 years of age at enrollment 3. Gestational age of โ‰ฅ32 weeks, 0 days at enrollment 4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation 5. Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study 6. Authorization obtained for the relevant HCP(s) to provide data to the registry 7. Contact information available (for participant and HCPs) Exclusion Criteria: * Individuals meeting any of the following criteria will not be included in the study: 1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation 2. Multi-fetal pregnancy 3. Enrolled in the RSV-PR with a previous pregnancy
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What it tests

  • RSV Vaccine
  • Non-exposure to RSV Vaccine
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Where

1 site
PPD
Wilmington, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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