Acceptance of Human Papillomavirus Vaccination in Postpartum Women

Completed

• Conditions: Human Papilloma Virus; HPV; Post Partum

• Registration Number: NCT00730704
• Lead Sponsor: Columbia University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Study Start: 2009-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States