Acceptance of Human Papillomavirus Vaccination in Postpartum Women
NCT ID: NCT00730704
Last Updated: 2012-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2009-05-31
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
26 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Columbia University
OTHER
Responsible Party
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Jason D. Wright
Assistant Professor of Gynecologic Oncology
Principal Investigators
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Jason Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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References
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Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F.
Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet. 2007 Sep 8;370(9590):890-907. doi: 10.1016/S0140-6736(07)61416-0.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.
Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, Taddeo FJ, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Koutsky LA; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43. doi: 10.1056/NEJMoa061760.
Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702. doi: 10.1016/S0140-6736(07)60777-6.
Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8. doi: 10.1016/S1470-2045(05)70101-7.
Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, Chiacchierini LM, Jansen KU; Proof of Principle Study Investigators. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002 Nov 21;347(21):1645-51. doi: 10.1056/NEJMoa020586.
Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-24.
Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents. J Low Genit Tract Dis. 2004 Jul;8(3):188-94. doi: 10.1097/00128360-200407000-00005.
Lazcano-Ponce E, Rivera L, Arillo-Santillan E, Salmeron J, Hernandez-Avila M, Munoz N. Acceptability of a human papillomavirus (HPV) trial vaccine among mothers of adolescents in Cuernavaca, Mexico. Arch Med Res. 2001 May-Jun;32(3):243-7. doi: 10.1016/s0188-4409(01)00277-6.
Slomovitz BM, Sun CC, Frumovitz M, Soliman PT, Schmeler KM, Pearson HC, Berenson A, Ramirez PT, Lu KH, Bodurka DC. Are women ready for the HPV vaccine? Gynecol Oncol. 2006 Oct;103(1):151-4. doi: 10.1016/j.ygyno.2006.02.003. Epub 2006 Mar 21.
Taylor JA, Darden PM, Brooks DA, Hendricks JW, Wasserman RC, Bocian AB; Pediatric Research in Office Settings; National Medical Association. Association between parents' preferences and perceptions of barriers to vaccination and the immunization status of their children: a study from Pediatric Research in Office Settings and the National Medical Association. Pediatrics. 2002 Dec;110(6):1110-6. doi: 10.1542/peds.110.6.1110.
Tissot AM, Zimet GD, Rosenthal SL, Bernstein DI, Wetzel C, Kahn JA. Effective strategies for HPV vaccine delivery: the views of pediatricians. J Adolesc Health. 2007 Aug;41(2):119-25. doi: 10.1016/j.jadohealth.2007.05.007.
Kahn JA, Zimet GD, Bernstein DI, Riedesel JM, Lan D, Huang B, Rosenthal SL. Pediatricians' intention to administer human papillomavirus vaccine: the role of practice characteristics, knowledge, and attitudes. J Adolesc Health. 2005 Dec;37(6):502-10. doi: 10.1016/j.jadohealth.2005.07.014.
Daley MF, Liddon N, Crane LA, Beaty BL, Barrow J, Babbel C, Markowitz LE, Dunne EF, Stokley S, Dickinson LM, Berman S, Kempe A. A national survey of pediatrician knowledge and attitudes regarding human papillomavirus vaccination. Pediatrics. 2006 Dec;118(6):2280-9. doi: 10.1542/peds.2006-1946.
Related Links
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Columbia University Department of Obstetrics and Gynecology
Other Identifiers
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AAAD1877
Identifier Type: -
Identifier Source: org_study_id