Acceptance of Human Papillomavirus Vaccination in Postpartum Women
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | May 2009 |
| End Date: | October 2012 |
| Contact: | Crystal L Miller, RN, BSN |
| Email: | clm2167@columbia.edu |
| Phone: | 212-305-5231 |
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.
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.
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.
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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