Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Implant Continuation
研究概览
简要总结
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
详细描述
Objective
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
Secondary Objectives:
To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to:
- report higher levels of satisfaction with their contraceptive implant at one year following initiation
- require less clinical follow-up and clinical resources in the year following initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •You are between ages of 14 to 22.9 years.
- •Started etonogestrel implant for the first time and have never used the implant before.
排除标准
- •There is any contraindication to estrogen containing birth control.
- •Desire of pregnancy in next 12 months.
- •Plans to move from the area in next 12 months and is not able to come to the clinic.
研究组 & 干预措施
COCR Arm
Participants in the COCR arm will receive three packs of combined oral contraceptive pills (35mcg ethinyl estradiol/norgestimate) and a specific protocol for their use for bothersome bleeding.
干预措施: Ethinyl Estradiol / Norgestimate Oral Tablet (Drug)
结局指标
主要结局
Implant Continuation
时间窗: 12 months post-insertion
We will assess continuation of use of the contraceptive implant.
次要结局
- Satisfaction with contraceptive implant(3, 6, and 12 months post-insertion)