Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale
研究概览
简要总结
This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,
详细描述
The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders
排除标准
- •1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol
研究组 & 干预措施
prostaglandins before iud insertion group
this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion
干预措施: Misoprostol (Drug)
结局指标
主要结局
Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale
时间窗: During the intervention
By using the visual analogue score
次要结局
- cervical dilataion < 4 mm(During the intervention)
- Pain at insertion according to VAS(During the intervention)
- Subjective sensation of satisfaction graduated as VAS like scale(During the intervention)
- side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting(During the intervention)
- Duration of insertion(min)(During the intervention)
- side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia(During the first 24 hours)
- side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion(After 30 days of intervention)
研究者
Hany saad
assisstant professor
Cairo University