The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- degree of pain during IUD insertion
研究概览
简要总结
The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females desiring contraception with the use of IUD
排除标准
- •Are pregnant or think they may be pregnant
- •Septic pregnancy or abortion
- •Have unexplained abnormal vaginal bleeding
- •Have untreated cervical cancer
- •Have malignant gestational trophoblastic disease
- •Have uterine cancer
- •Have uterine abnormalities
- •Have or may have had a pelvic infection within the past three months
- •Have or may have any sexually transmitted disease
- •Have pelvic tuberculosis
- •Are postpartum between 48 hours and 4 weeks
- •Have benign gestational trophoblastic disease
- •Have ovarian cancer
- •Have AIDS (unless clinically well on anti-retroviral therapy)
研究组 & 干预措施
Non touch technique
the intrauterine device TCu 380A will be inserted in the conventional method as follows: First, insert the speculum and view the cervix. The position of the cervix will very often confirm if the uterus is anteverted or retroverted. Second, using the Allis forceps hold the back of a cotton-ball swab and dip it into a povidine-iodine disinfectant solution, or equivalent. Swab the cervix. Then cut the threads to the appropriate length and remove the speculum.
This technique omits the sounding of the uterus which is considered a quintessential procedure before IUD insertion for which there is no one established piece of evidence.The IUD is checked afterwards by transvaginal ultrasound.
干预措施: intrauterine device TCu 380A (Device)
Traditional IUD insertion
the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.
干预措施: intrauterine device TCu 380A (Device)
结局指标
主要结局
degree of pain during IUD insertion
时间窗: 5 months
Pain will be assessed by the use of visual analog scale (VAS).
次要结局
未报告次要终点
研究者
Dina Mohamed Refaat Dakhly
Lecturer of Obstetrics and Gynecology
Woman's Health University Hospital, Egypt