Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial.

ABSTRACT:

Objective

To examine the effect of the bivalent human papillomavirus (HPV) vaccine on miscarriage.

Design

Observational long term follow-up of a randomized, double blinded trial combined with an independent unvaccinated population based cohort.

Setting

Single center study in Costa Rica.

Participants

7466 women in the trial and 2836 women in the unvaccinated cohort enrolled at the end of the randomized trial and in parallel with the observational trial component.

Intervention

Women in the trial were assigned to receive three doses of bivalent HPV vaccine (n=3727) or the control hepatitis A vaccine (n=3739). Crossover bivalent HPV vaccination occurred in the hepatitis A vaccine arm at the end of the trial. Women in the unvaccinated cohort received (n=2836)

SUBMITTER: Panagiotou OA 

PROVIDER: S-EPMC4561367 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature