Acceptance of Human Papillomavirus Vaccination in Postpartum Women

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.

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Key information

Conditions

Human Papilloma Virus HPV Post Partum

Age range

18 year–26 year

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

Primary Objective

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

Secondary Objectives

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Acronym: HPV Acceptance

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Aug 8, 2008
Registry last updated: Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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