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临床试验/NCT04725643
NCT04725643进行中(未招募)不适用

Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
55
试验地点
1
主要终点
Number of bleeding days during 4 weeks before replacement

研究概览

简要总结

The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.

详细描述

There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement.

The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys.

Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive aged women 18-50 years old
  • With a contraceptive implant (for patient participants)
  • Able to consent in English
  • Palpable contraceptive implant

排除标准

  • Non-palpable contraceptive implant

结局指标

主要结局

Number of bleeding days during 4 weeks before replacement

时间窗: 4 weeks (28 days) before day of implant replacement.

Number of days participants experienced bleeding during the 4 weeks before implant replacement.

Number of bleeding days 4 weeks after replacement

时间窗: 4 weeks (28 days) after day of implant replacement

Number of days participants experienced bleeding during the 4 weeks after implant replacement.

次要结局

  • Satisfaction with bleeding before replacement(4 weeks (28 days) before day of implant replacement)
  • Number of bleeding days during the second month after implant replacement(Second month (defined as 29-56 days) after implant replacement)
  • Number of bleeding days during the third month post replacement(Third month (defined as 57-84 days) after implant replacement)
  • Satisfaction with bleeding after replacement(4 weeks (28 days) after day of implant replacement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Mody

Associate Professor

University of California, San Diego

研究点 (1)

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