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CompletedNCT00730704HPV AcceptanceUpdated Nov 4, 2012

Acceptance of Human Papillomavirus Vaccination in Postpartum Women

An observational study in Human Papilloma Virus, HPV and Post Partum, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2012-11-04.

Sponsored by Columbia University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 26 Years
Sex
Female
01

Study 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.

Read the 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.
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Conditions studied

  • Human Papilloma Virus
  • HPV
  • Post Partum

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Keywords

  • Human Papilloma Virus vaccines
  • HPV
  • Gardasil
  • Post partum
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In context

Papilloma

234 studies on the registry are indexed under Papilloma; 28 are open to participants now.

This study's enrollment of 150 is below the median of 188 across 64 observational studies indexed under Papilloma.

Browse Papilloma studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women, aged 18-26, hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.

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

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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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (actual)
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Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
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References and documents

Publications

  • 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. PubMed 15761078 ↗
  • 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. PubMed 10451482 ↗
  • 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. PubMed 17826171 ↗
  • 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. PubMed 17494925 ↗
  • 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. PubMed 17494926 ↗
  • 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. PubMed 17512854 ↗
  • 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. PubMed 15863374 ↗
  • 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. PubMed 12444178 ↗
  • 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. PubMed 17380109 ↗
  • 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. PubMed 15874862 ↗
  • 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. PubMed 11395192 ↗
  • 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. PubMed 16551476 ↗
  • 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. PubMed 12456907 ↗
  • 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. PubMed 17659214 ↗
  • 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. PubMed 16310128 ↗
  • 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. PubMed 17142510 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00730704
Lead sponsor
Columbia University
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Jason D. Wright (Assistant Professor of Gynecologic Oncology, Columbia University) — Principal investigator
First posted
Aug 8, 2008
Start date
May 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Nov 4, 2012

Study contacts

Jason Wright, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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