Nexplanon Observational Risk Assessment Study (NORA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,364
- 试验地点
- 1
- 主要终点
- Insertion-, localization- and removal-related events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women prescribed a new Nexplanon implant
- •Women who are capable of understanding the major aspects of the study and can complete the self-administered questionnaire in English
排除标准
- •Women who are not willing to sign the informed consent form
结局指标
主要结局
Insertion-, localization- and removal-related events
时间窗: Within 42 months after insertion
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.
次要结局
- Pregnancy outcomes(Within 42 months after insertion)
- Reasons for (premature) discontinuation of Nexplanon(Within 42 months after insertion)
- Pregnancy(Within 42 months after insertion)
- Baseline characteristics of Nexplanon users(Within 42 months after insertion)
研究者
Klaas Heinemann, MD, PhD
Principal Investigator
Center for Epidemiology and Health Research, Germany