Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The degree of pain perception measured visual analogue score
研究概览
简要总结
The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.
The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.
The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women requesting intrauterine contraceptive device as a contraction
- •Women accepted participation in the study
排除标准
- •Uterine abnormalities
- •Endometrial lesions as polyp
- •Adenomyosis
- •Fibroids distorting the cavity
- •Intrauterine adhesions.
- •Chronic pelvic pain
- •Dysmenorrhea
- •History of cervical surgery
研究组 & 干预措施
Group I: IUD without uterine sound group
Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
干预措施: IUD (Other)
Group I: IUD without uterine sound group
Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
干预措施: Transvaginal ultrasound (Radiation)
Group II: IUD with uterine sound
Intrauterine contraceptive device inserted by classic method
干预措施: IUD (Other)
Group II: IUD with uterine sound
Intrauterine contraceptive device inserted by classic method
干预措施: Uterine sounding (Other)
结局指标
主要结局
The degree of pain perception measured visual analogue score
时间窗: 15 minutes
次要结局
未报告次要终点