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临床试验/NCT04558229
NCT04558229进行中(未招募)4 期

Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant

Planned Parenthood of the St. Louis Region and Southwest Missouri1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2020年11月24日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
348
试验地点
1
主要终点
Nexplanon Discontinuation Rates

研究概览

简要总结

Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
  • •Ability to consent in English

排除标准

  • •Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

研究组 & 干预措施

Standard of Care Clinician Counseling

No Intervention

Additional Standardized Counseling

Experimental

干预措施: Additional Standardized Counseling (Other)

结局指标

主要结局

Nexplanon Discontinuation Rates

时间窗: 6 months

Based subjects' self-reported ability to cope with various changes in bleeding patterns, and other demographic information, we will analyze whether an association exists between those who discontinue their method use early due to troublesome bleeding and the counseling they received on the day of method insertion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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