Feasibility Study of IUD Placement Without Sounding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.
研究概览
简要总结
The purpose of this study is to determine the feasibility of a uterine sound sparing technique for levonorgestrel 52 mg intrauterine device (IUD) placement. This study will be conducted in three phases. In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. Phase two and three are interventional phases that will investigate IUD placement without the use of a uterine sound. In phase two, the IUD will be placed without the use of a uterine sound, but under abdominal ultrasound guidance. In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance. An ultrasound exam will be completed at the end of phase two and three to determine if the IUD was successful placed. To answer the secondary objectives, for all study phases the investigators will measure the procedure time, the participant-reported maximum pain during and 5-minutes post placement and the provider assessment of ease of placement. To determine the exploratory objective of IUD expulsion and perforation rate for a uterine sound sparing IUD placement technique, participants in phases two and three will complete a 30-day phone follow up and 90-day in clinic follow up to evaluate for IUD expulsion or perforation. The investigators hypothesize that the levonorgestrel 52 mg IUD can successfully be inserted without uterine sounding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age ≥18 years
- •Patients undergoing a levonorgestrel 52 mg IUD placement for contraception at a UC Davis outpatient clinic, who have signed consent for placement and are candidates for levonorgestrel 52 mg IUD placement based on the clinical judgement of their UC Davis Ob-Gyn provider.
排除标准
- •Women with prior failed IUD placement
- •Women with known uterine anomalies or uterine fibroids that distort the uterine cavity
- •Women with known cervical stenosis
结局指标
主要结局
Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.
时间窗: Ultrasound completed at end of IUD placement procedure to determine if successfully placed in the correct location.
Successful placement without a uterine sound defined as ultrasound confirmation of IUD in the uterine cavity following placement. Outcomes will be compared between experimental phases two and three.
次要结局
- Total time of IUD placement measured in minutes(Measured once on day of IUD placement)
- Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale(Measured once on day of IUD placement)
- Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale(Measured once on day of IUD placement)
- Provider assessment of ease of placement defined as an easy, moderate or difficult placement.(Measured once on day of IUD placement)
- IUD expulsion and perforation rate during first three months after placement with sound-sparing technique(Measured at time of IUD insertion and three month clinic follow up three months after IUD placement)