Status:

WITHDRAWN

HPV Vaccine in Postpartum Women

Lead Sponsor:

Milton S. Hershey Medical Center

Conditions:

HPV Infection

Eligibility:

FEMALE

18-26 years

Brief Summary

The purpose of this study is to determine the acceptability of HPV vaccination in postpartum women in Central Pennsylvania. Participants will be recruited while inpatient in the postpartum unit. Parti...

Detailed Description

The purpose of this pilot study is to determine if postpartum women serve as a potential population to target in order to increase human papillomavirus (HPV) vaccination in Central Pennsylvania. Desp...

Eligibility Criteria

Inclusion

  • Women postpartum with a live birth at Penn State Hershey Medical Center (PSHMC), either vaginal or cesarean delivery.
  • Women aged 18-26 (inclusive) years
  • Women who are on a Floor Status level of care.
  • Women who have completed 0 or 1 doses of the HPV vaccine STUDY00013831 Approval: 5/8/2020 Page 6 of 24 (V.01/21/2019)
  • Fluent in written and spoken English and other languages in which the Human Subjects Protection Office (HSPO) Consent Short From is available (French, Italian, Russian, Spanish, Vietnamese, Hindi, Chinese and Nepali)

Exclusion

  • Women who have completed 2 or 3 doses of the HPV vaccine
  • Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL®.
  • Allergic reaction to amorphous aluminum hydroxyphosphate sulfate or polysorbate 80
  • Women being actively treated for cancer.
  • Have a fever over 100.4 degrees Fahrenheit (38.0 degrees Celsius)
  • Women who are at an ICU level of Care
  • Women who are on a Labor and Delivery Level of Care
  • Women receiving continuous IV magnesium.

Key Trial Info

Start Date :

September 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2023

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04430907

Start Date

September 1 2021

End Date

September 1 2023

Last Update

July 2 2021

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