A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Continuation Rate
研究概览
简要总结
The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number 4)No contraindications to receiving this method of contraception, which include: known or suspected pregnancy, active liver disease or hepatic tumor, current or past history of thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or suspected breast cancer or history of breast cancer, hypersensitivity to any of the components of the device.
排除标准
- •Not meeting inclusion criteria
- •Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:
- •Non-nucleoside reverse transcriptase inhibitors
- •ritonavir-boosted protease inhibitors
- •Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine
- •St. John's Wort
研究组 & 干预措施
Immediate Postpartum Etonogestrel Implant
Etonogestrel implant placed in the hospital after delivery, before discharge home.
干预措施: Etonogestrel implant (Drug)
Delayed postpartum etonogestrel implant
These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
干预措施: Etonogestrel implant (Drug)
结局指标
主要结局
Continuation Rate
时间窗: 1 year
To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.
次要结局
- Rate of Intercourse(6 weeks)
- Continuation Rate(6 months)