Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the difference in the pain intensity scores between the study groups
研究概览
简要总结
To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.
详细描述
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.
排除标准
- •currently pregnant or were pregnant within 6 weeks of study entry
- •had a prior attempted or successful IUD insertion
- •had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
- •any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
- •active vaginitis or cervicitis
- •undiagnosed abnormal uterine bleeding
- •pelvic inflammatory disease within the last 3 months
- •fibroids or other uterine abnormalities distorting the uterine cavity
- •contraindication or allergy to dinoprostone.
研究组 & 干预措施
dinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.
干预措施: Dinoprostone (Drug)
placebo
one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.
干预措施: placebo (Drug)
结局指标
主要结局
the difference in the pain intensity scores between the study groups
时间窗: 5 minutes
the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain
次要结局
未报告次要终点
研究者
Ahmed Samy aly ashour
assistant professor
Cairo University