[Preliminary results from the OPNI observatory: long-term follow-up of a cohort of women using the progestagen contraceptive implant Implanon].
Fiche publication
Date publication
mai 2005
Auteurs
Membres identifiés du Cancéropôle Est :
Pr GRAESSLIN Olivier
Tous les auteurs :
Graesslin O, Hoffet M, Barjot P, Levy A, Bouee S, Bogillot O, Heu N, Madelenat P
Lien Pubmed
Résumé
OBJECTIVE: Describe the initiation and follow-up of Implanon insertion in current office-based practice in France and estimate the rate and causes of early removals. PATIENTS AND METHODS: A prospective cohort study of 1000 women having been inserted with Implanon by a representative national sample of prescribers (gynaecologists and general practitioners) was designed. The follow-up period was 3 years and the enrolment was planned for 2 years starting July 2002 according to a naturalistic design. RESULTS: The results are related to an intermediate analysis describing the situation of the cohort at the date 31 December 2003. 872 women were enrolled, of whom 784 (89.9%) by gynaecologists and 88 (10.1%) by GPs. Implanon was inserted in 691 (79.2%) and 360 (52.1%) had at least one follow-up visit at this date. The mean follow-up period after insertion was 10.5 months. 38 early removals were recorded (actuarial rate at 16 months of 8.8% [CI 95% 5.0-12.7]), integrating the distribution of follow-up duration and the assumption that women with no follow-up visit the still had device. DISCUSSION AND CONCLUSION: The estimated early removal rate was lower than the result of the meta-analysis of international clinical trials but this figure should be confirmed in the final analysis of the study.
Référence
Gynecol Obstet Fertil. 2005 May;33(5):315-21