Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Insertion rates of implantable birth control
研究概览
简要总结
This is a pilot study in which women who desire an etonogestrel implant will be randomized to either a home or office insertion visit. The purpose of this research is to study the interest in, feasibility of, and rates of insertion for implantable birth control (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office visit appointments.
The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant and increase consistent and correct contraception use by introducing a previously unexplored method of access, the home visit.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 and over
- •Was pregnant within the last 10 weeks
- •Interested in using the etonogestrel implant for contraception
- •Willing to have investigators come to the home for an insertion visit
- •Presenting to University Hospitals for delivery or contraception.
- •Has running water and a working bathroom in the home
- •Has a safe and private location in the home for the implant to be inserted
排除标准
- •Current or history of thrombosis or thromboembolic disorders
- •Liver tumors or active liver disease
- •Undiagnosed abnormal genital bleeding
- •Known or suspected breast cancer or history of breast cancer
- •Allergic reaction to components (ethylene vinylacetate, etonogestrel, barium sulfate) of etonogestrel implant or local anesthetics
- •Women currently taking hepatic enzyme inducers including but not exclusive to barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenylbutazone, phenytoin, rifampin, topiramate, protease inhibitors, and St. John's wort
- •Uncontrolled hypertension
- •Housing located greater than 10 miles from University Hospitals Center for Women's Health
- •The location of the home is in a place that would not be safe for investigators
- •Participant is homeless
研究组 & 干预措施
Home Visit
20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.
干预措施: Home Visit (Procedure)
Office Visit
20 participants will be randomized to receive an office visit (standard of care).
干预措施: Office visit (Procedure)
结局指标
主要结局
Insertion rates of implantable birth control
时间窗: Two weeks post-implant insertion at the follow-up telephone call
Assess rates of insertion of etonogestrel contraceptive implant in women randomly assigned to home visits or standard office visits.
次要结局
- Interest in home visit option(Within 6-8 weeks of enrollment)
- Rates of return for postpartum follow-up(Within 6-8 weeks of enrollment)
研究者
Suji Uhm
MD/MPH Student
Case Western Reserve University