Know Cancer

or
forgot password

Acceptance of Human Papillomavirus Vaccination in Postpartum Women


N/A
18 Years
26 Years
Not Enrolling
Female
Human Papilloma Virus, HPV, Post Partum

Thank you

Trial Information

Acceptance of Human Papillomavirus Vaccination in Postpartum Women


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Jason Wright, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Food and Drug Administration

Study ID:

AAAD1877

NCT ID:

NCT00730704

Start Date:

May 2009

Completion Date:

October 2012

Related Keywords:

  • Human Papilloma Virus
  • HPV
  • Post Partum
  • Human Papilloma Virus vaccines
  • HPV
  • Gardasil
  • Post partum
  • Papilloma

Name

Location

Columbia University Medical CenterNew York, New York  10032