The PAINLESS Study: Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain during insertion of the IUS
研究概览
简要总结
Rationale: The 2019 Belgian Health Survey shows that the combined oral contraceptive pill is the most commonly used form of contraception. However, the Pearl index of Long-acting reversible contraceptive (LARC) methods is significantly better (perfect and typical use <0.5) compared to the combined oral contraceptive pill (perfect use <1.0, typical use 2-9). An IUS is an example of a LARC method. IUS insertion might be painful. Because of this, women may be reluctant to opt for an IUS. The traditional technique for an IUS insertion uses a speculum after which a Pozzi tenaculum is placed on the cervix so that the uterus is brought into the stretching position by means of traction. The cavum is then measured by a uterine sound. These actions and the use of these instruments can contribute to the pain experience during insertion. The new technique, transabdominal sonographic (TAS) insertion, could reduce the pain experience during insertion. This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings. Little high quality studies have been conducted on the advantages and disadvantages of the TAS technique as demonstrated by a non-published systematic review of the literature.
Research question/goal: Is the insertion of an IUS (Kyleena/Mirena) using the TAS technique less painful than the traditional technique?
Study design: A randomized trial (RCT) in which the subject is blinded to the insertion technique.
Study population: Women wishing an IUS (Kyleena & Mirena)
Primary and secondary outcomes:
The primary outcomes are the pain during insertion (Numeric Rating Scale (NRS) score 0-10) and dislocation: non-fundal position (> 3mm fundal distance postinsertion) in the uterine cavity (Y/N).
Secondary outcomes include the average and worst pain in the first week after insertion (NRS 0-10), expulsion of the IUS, perforation of the uterine wall, failure of insertion, the occurrence of vagal symptoms, use of pain relief the first 7 days after placement, subject satisfaction about the procedure, successful IUS placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between18 years and 60 years (at the time of signing the ICF)
- •Who wish to have an IUS (Kyleena/Mirena) for reasons of family planning, conservative treatment for abnormal uterine bleeding or as part of hormonal treatment for menopausal symptoms
- •Dutch-speaking subjects
排除标准
- •History of difficult IUS placement
- •Known cervical stenosis
- •Asherman's syndrome
- •Standard contraindications to an IUS (eg breast cancer, recent deep vein thrombosis, anatomical uterine abnormalities, pregnancy, acute PID, cervicitis, vaginitis or any lower genital tract infection, cervical or endometrial malignancy, history of septic abortion or postpartum endometritis in the last 3 months,.. )
- •Current pelvic inflammatory disease
- •Pregnancy
- •Trophoblastic disease
- •Known cervical or endometrial carcinoma
- •Patients who have the profession of midwife, nurse or doctor.
研究组 & 干预措施
The TAS (transabominal ultrasound) insertion technique
This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings.
干预措施: IUS (intrauterine system) insertion (Procedure)
The Traditional Technique
The traditional technique for an IUS insertion uses a speculum after which a Pozzi tenaculum is placed on the cervix so that the uterus is brought into the stretching position by means of traction. The cavum is then measured by a uterine sound. These actions and the use of these instruments can contribute to the pain experience during insertion.
干预措施: IUS (intrauterine system) insertion (Procedure)
结局指标
主要结局
Pain during insertion of the IUS
时间窗: From enrollment to the intervention date (IUS placement)
Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10
Dislocation
时间窗: From enrollment to intervention date (IUS placement)
Dislocation: non-fundal position (\> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)
Pain during insertion of the IUS
时间窗: From enrollment to the intervention date (IUS placement)
Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10
Dislocation
时间窗: From enrollment to intervention date (IUS placement)
Dislocation: non-fundal position (\> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)
次要结局
- Failure of insertion(During the procedure of IUS placement)
- Satisfaction with the procedure(Seven days after IUS placement)
- Successful IUS placement(Directly after IUS insertion procedure)
- Expulsion(During of directly after the intervention (IUS placement))
- vagal symptoms(During IUD insertion)
- Pain experience during 7 days after placement(During the 7 days after IUS insertion)
- Pain relief taken during the 7 days after IUS placement(During the 7 days after IUS placement)
- Perforation(During IUS placement)