Effects of Prophylactic Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Provider ease of insertion
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 nulliparous 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.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a first line of contraception in nulliparous women.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test.
排除标准
- •• a prior pregnancy greater than 20 weeks of duration
- •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 to dinoprostone.
研究组 & 干预措施
dinoprostone arm
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.
干预措施: Dinoprostone 3 mg (Drug)
placebo
one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.
干预措施: placebo vaginal tablet (Drug)
结局指标
主要结局
Provider ease of insertion
时间窗: 5 minutes
Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.
次要结局
- the difference in the pain intensity scores between the study groups(5 minutes)
- insertion time(10 minutes)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University