Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Cervical dilatation
研究概览
简要总结
The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.
详细描述
Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women
- •No chirurgical procedure in the cervix
- •Wish to use IUD as a contraceptive method
- •Exclusion criteria are as follows:
- •Presence of active cervical infection visible upon speculum exam (purulent cervicits)
- •Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
- •Pregnancy ending less than 6 weeks prior to enrollment in study
- •History of prior IUD placement
- •History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
- •History of uterine surgery
- •Allergy or intolerance to misoprostol or other prostaglandin
- •Undiagnosed abnormal vaginal bleeding
- •Malignancy of the genital tract
- •Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
- •Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)
排除标准
- 未提供
研究组 & 干预措施
Vaginal Misoprostol Group
Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion
干预措施: Vaginal misoprostol (Drug)
Placebo group
Vaginal placebo tablets 4 hours prior to IUD insertion
干预措施: Vaginal misoprostol (Drug)
结局指标
主要结局
Cervical dilatation
时间窗: four hours after misoprostol use
the frequency of women with cervical dilation ≤ 4 mm (measured by inserting a #4 Hegar dilator through the internal orifice of the cervix uteri immediately prior to IUD insertion
次要结局
- Difficulty in inserting IUD(four hours after misoprostol use)
- Pain at insertion(four hours after misoprostol use)
研究者
Melania Amorim
PhD
Instituto Materno Infantil Prof. Fernando Figueira