Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 916
- 试验地点
- 1
- 主要终点
- Contraceptive Method Discontinuation
研究概览
简要总结
In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.
详细描述
In this partially randomized patient preference study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24-month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method. It is expected that 38% of the participants using short-acting methods will stop using them during the first year and be at risk of unintended pregnancy. In contrast, less than 20% of LARC users will want to have their contraceptive removed. Continuation rates will be measured and pregnancies will be tallied in the two groups to document any differences that emerge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 to 29 years of age;
- •sexually active;
- •seeking oral or injectable contraception;
- •working cell phone;
- •working email account;
- •willingness to be contacted by the clinic staff or study coordinators; and,
- •willingness to complete questionnaires.
排除标准
- •currently pregnant;
- •previous use of a long-acting reversible contraceptive (LARC) method; and,
- •medical contraindications for oral contraceptives and injectables.
研究组 & 干预措施
Preference SARC
Participants received one of a variety of oral contraceptives or DMPA
干预措施: DMPA (Drug)
Preference SARC
Participants received one of a variety of oral contraceptives or DMPA
干预措施: oral contraceptives (Drug)
Randomized LARC
Participants receive one of the following interventions:
Implanon® or Nexplanon®; ParaGard®; Mirena®
干预措施: Implanon® (Drug)
Randomized LARC
Participants receive one of the following interventions:
Implanon® or Nexplanon®; ParaGard®; Mirena®
干预措施: ParaGard® (Drug)
Randomized LARC
Participants receive one of the following interventions:
Implanon® or Nexplanon®; ParaGard®; Mirena®
干预措施: Mirena® (Drug)
Randomized SARC
Participants received one of a variety of oral contraceptives or DMPA
干预措施: DMPA (Drug)
Randomized SARC
Participants received one of a variety of oral contraceptives or DMPA
干预措施: oral contraceptives (Drug)
结局指标
主要结局
Contraceptive Method Discontinuation
时间窗: 24 months
次要结局
- Participant Attitudes to LARC vs SARC(24 months)
- Unintended Pregnancy(24 months)
