Status:
COMPLETED
Acceptance of Human Papillomavirus Vaccination in Postpartum Women
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Human Papilloma Virus
HPV
Eligibility:
FEMALE
18-26 years
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. ...
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 vaccin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00730704
Start Date
May 1 2009
End Date
October 1 2012
Last Update
November 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center
New York, New York, United States, 10032