Acceptance of Human Papillomavirus Vaccination in Postpartum Women (HPV Acceptance)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jason D. Wright, Columbia University
ClinicalTrials.gov Identifier:
NCT00730704
First received: August 4, 2008
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

Worldwide cervical cancer remains a major cause mortality among women. It is estimated that each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die from the disease. While the implementation of widespread screening programs has reduced the burden of cervical cancer, a large percentage of the population still remains unscreened or is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary precursor for the development of cervical cancer. The first vaccine to prevent HPV was recently approved by the Food and Drug Administration and is now available at doctors offices. Despite the availability of a safe and effective means for the prevention of cervical cancer, widespread implementation of vaccination has been extremely difficult. Several potential issues have limited the development of widespread HPV vaccination programs, including cultural and religious beliefs, and limitations in the practicality of administering the vaccine. The overall goals of our work are to improve access to preventive strategies for cervical cancer. In this proposal we will examine the strategy of HPV vaccination for women who have just given birth. We believe that HPV vaccination of these women will be associated with a high level of patient satisfaction and acceptance. If successful, this strategy could play a major role in advancing the acceptance and implementation of HPV vaccination in the United States.


Condition
Human Papilloma Virus
HPV
Post Partum

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acceptance of Human Papillomavirus Vaccination in Postpartum Women

Resource links provided by NLM:


Further study details as provided by Columbia University:

Enrollment: 150
Study Start Date: May 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Primary Objective

1. To estimate compliance with the HPV vaccine series when initiated in postpartum women.

Secondary Objectives

  1. To determine patient acceptance and satisfaction with HPV vaccination administered in the postpartum period.
  2. To determine predictors of compliance with the HPV vaccination series.
  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women, aged 18-26, hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.

Criteria

Inclusion Criteria:

  • Age 18-26 years.
  • Patients hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.
  • Patients who delivered a singleton fetus or multiple gestations are eligible for participation.
  • Patients may have delivered at gestational ages 32-44 weeks.
  • Patients must have signed informed consent.
  • Patients must meet pre-entry criteria.
  • Patients who are breast feeding are eligible for participation.
  • Patients must have an obstetrician whom they have seen for obstetric care and plan to follow-up with in the postpartum period.

Exclusion Criteria:

  • Age < 18 or > 26 years.
  • Patients with hemophilia, other bleeding disorders or thrombocytopenia (platelets < 100,000/ul).
  • Patients receiving active anticoagulant therapy with warfarin, heparin or low molecular weight heparin.
  • Pregnancy or planning pregnancy within the next 6 months.
  • Ongoing bacteremia, endomyometritis or other serious febrile illness.
  • Hypersensitivity to yeast, aluminum or other vaccine components.
  • Prior vaccination with a prophylactic HPV vaccine (single or multiple doses).
  • Patients who delivered a non-viable infant or an infant with severe congenital malformations.
  • Patients who do not plan on following up postpartum with their local obstetrician or maternal fetal medicine specialist.
  • Patients who are unwilling to receive subsequent doses of the HPV vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730704

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jason Wright, MD Columbia University
  More Information

Additional Information:
Publications:
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55(2):74-108.
Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet 2007;370(9590):890-907

Responsible Party: Jason D. Wright, Assistant Professor of Gynecologic Oncology, Columbia University
ClinicalTrials.gov Identifier: NCT00730704     History of Changes
Other Study ID Numbers: AAAD1877
Study First Received: August 4, 2008
Last Updated: November 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Human Papilloma Virus vaccines
HPV
Gardasil
Post partum

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014