Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 4
- 主要终点
- Intention-to-treat Analysis of Etonogestrel Implant Use
研究概览
简要总结
Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.
详细描述
Women will be contacted 6 months after their abortion to ask about contraception use and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older,
- •an intrauterine pregnancy > 14 weeks and <23 6/7 weeks gestation and desire termination of pregnancy
- •desire a Nexplanon for contraception
- •able to give informed consent in English
- •no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D&E
排除标准
- •unable to give informed consent
- •have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
- •non-surgical management of pregnancy
- •prior participation in this study
- •breast cancer or a history of breast cancer
结局指标
主要结局
Intention-to-treat Analysis of Etonogestrel Implant Use
时间窗: 6 months
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations.
Per-protocol Analysis of Etonogestrel Implant Use
时间窗: 6 months
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations.
次要结局
- Repeat Pregnancy(6 months)
研究者
Allison Cowett, MD MPH
Associate Medical Director
Family Planning Associates Medical Group, LTD