Nexplanon Observational Risk Assessment Study (NORA)
This study characterises the frequency of specific insertion-, localization- and removal-related events and clinically significant consequences thereof among Nexplanon users in the US during routine clinical use.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Nexplanon Observational Risk Assessment Study (NORA)|
- Insertion-, localization- and removal-related events [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: Yes ]Incorrect insertion (i.e. unrecognized non-insertion, partial insertion, deep insertion); palpability of the implant at insertion and removal; localization of a non-palpable implant; difficult removals; pregnancy due to unrecognized non-insertion of the implant; injury to neurovascular structures in the arm; hospitalization and/or surgical procedures for localization and/or removal.
- Pregnancy and pregnancy outcomes [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: Yes ]
- Reasons for (premature) discontinuation of Nexplanon [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: Yes ]
- Baseline characteristics of Nexplanon users [ Time Frame: Within 42 months after insertion ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
|New users of Nexplanon|
Nexplanon is a subdermal contraceptive implant containing the progestogen etonogestrel. It provides contraceptive protection for three years. In addition to the progestogen, Nexplanon contains barium sulfate and a Next Generation Implanon Applicator (NGIA). Nexplanon was developed to further facilitate correct insertion of the implant by using the NGIA, and to extend the diagnostic modalities for localization of the implant by making it radiopaque and visible via X-ray imaging and X-ray Computerized Tomography (CT).
A large, descriptive, prospective, non-interventional, observational cohort study is planned to follow a cohort of new users of the contraceptive implant Nexplanon. Women will be recruited through health care professionals who have completed the Nexplanon Clinical Training Program. Baseline and follow-up information will be collected via a self-administered questionnaire. Data analysis will include characterizing the frequency of specific insertion-, localization- and removal-related events via point-estimates of the event rate as well as 95% confidence intervals. The impact of potential prognostic factors will be analyzed using multivariate regression models and/or stratified analyses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473641
|Center for Epidemiology and Health Research|
|Principal Investigator:||Klaas Heinemann, MD, MBA, PhD||Center for Epidemiology and Health Research, Berlin, Germany|