Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Successful Placement
研究概览
简要总结
This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc.
Twenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.
详细描述
Nulliparous patients undergoing IUD insertion will administer EMLA cream by menstrual disc or cervical cap prior to insertion. The medical provider will ensure proper placement of the cap or disc and perform a bi-manual exam to assess the patient's uterine position. A seven minute timer will be set, the cap/disc will be removed, and the provider will proceed with the IUD insertion according to manufacturer technique.
Visual Analog Scale (VAS) scores will be used throughout the procedure to assess participant pain throughout insertion. Participants and providers will report on pain, side effects, and procedure complications immediately after the procedure.
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
盲法说明
This is an open label study that involves no masking
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic
- •Able to review and sign study consents in English
- •Generally healthy
排除标准
- •History of any prior births, miscarriages, or abortions after 16 weeks' gestation
- •Currently pregnant, known or suspected
- •Current stringless IUD in place
- •Participants premedicated with misoprostol
- •History of chronic pelvic pain which patients take daily medication for
- •History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)
- •Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)
- •Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap
- •Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap
- •Previous IUD placement or failed attempt of an IUD placement
- •Weight < 54.4kg (120 lbs)
- •Plan for use of oral anxiolysis, moderate/deep sedation, or narcotics for procedure
- •Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate/deep sedation, or narcotics
- •Any planned concomitant procedures, such as dilation and curettage (D&C), endometrial biopsy, colposcopy, hysteroscopy, etc.
- •Illicit drug use
研究组 & 干预措施
Menstrual disc
Participants will be provided with a menstrual disc filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the disc. The provider will return to the room, make sure the disc is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the disc or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.
干预措施: Menstrual disc with EMLA cream (Combination Product)
Cervical cap
Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the cap. The provider will return to the room, make sure the cap is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the cap or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.
干预措施: Cervical cap with EMLA cream (Combination Product)
结局指标
主要结局
Successful Placement
时间窗: Immediately after IUD placement procedure
The number of participants able to correctly place the cap or disc as instructed, assessed by provider
Satisfaction with pain control
时间窗: Immediately after IUD placement procedure
Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology.
次要结局
- Ease of cap/disc placement(Immediately after IUD placement procedure)
- Protocol deviations(Immediately after IUD placement procedure)
- Ease of IUD placement(Immediately after IUD placement procedure)
- Procedure complications(Immediately after IUD placement procedure)
- Typical menstrual pain(On the day of IUD placement procedure prior to cap/disc placement and IUD placement)
- Pain during IUD placement procedure(Measured throughout IUD placement procedure immediately before the procedure, during placement of disc/cap, during speculum placement, during tenaculum placement, during sounding, during IUD placement, and 5 minutes after completion)
- Acceptability of pain mangement(one day post-procedure)
- Ease of cap/disc placement(Immediately after IUD placement procedure)
- Protocol deviations(Immediately after IUD placement procedure)
- Ease of IUD placement(Immediately after IUD placement procedure)
- Procedure complications(Immediately after IUD placement procedure)
- Typical menstrual pain(On the day of IUD placement procedure prior to cap/disc placement and IUD placement)
- Pain during IUD placement procedure(Measured throughout IUD placement procedure immediately before the procedure, during placement of disc/cap, during speculum placement, during tenaculum placement, during sounding, during IUD placement, and 5 minutes after completion)
- Acceptability of pain mangement(one day post-procedure)
研究者
Julia Tasset
Principal Investigator
Oregon Health and Science University