Vaginal Versus Sublingual Misoprostol Before Intrauterine Device Insertion in Women With Pervious Caesarian Section
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The proportion of easy IUD Insertion
研究概览
简要总结
Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
详细描述
Intrauterine devices (IUDs) are widely used as reversible contraceptives. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally.
Misoprostol is an inexpensive PGE1. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D&C) in premenopausal women resulted in an increased cervical dilatation and rate of cervical laceration. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. The effect of misoprostol is dependent on the route of administration. Sublingual administration of misoprostol has been shown to be more effective also for cervical priming compared with oral administration and equally effective as vaginal administration.
larger studies on the effect of misoprostol for IUD insertion are lacking. Investigator therefore will conduct a trial aiming to compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30.
排除标准
- •Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis).
- •Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate.
结局指标
主要结局
The proportion of easy IUD Insertion
时间窗: 24 hours
Difficulty of IUD insertion will be measured by cervical dilatation that determined by two factors: 1. Degree of dilatation of cervix by using gradual Hegar 1, 2, 3. 2. The degree of difficulty of the IUD insertion judged as the resistance of the internal cervical os experienced by the investigator and classified as 'easy', 'moderate' or 'difficult'. \[Time Frame: Easy: Using Hegar 3 and easy of difficulty of insertion. Moderate: Using Hegar 2 and moderate of difficulty of insertion. Difficult: Using Hegar 1 and difficult of difficulty of insertion\]
次要结局
- the pain during insertion(24 hours)
研究者
Rofida Mohamed Arafa Taha
Director
Ain Shams University