Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
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
- 是
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
Sheila Mody
Associate Professor
University of California, San Diego
