NCT02643186Unknown4 期
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- estimated intraoperative blood loss measured in milliliters
研究概览
简要总结
The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
- •abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
- •pain (dull aching lower abdominal pain or dysmenorrhea)
- •pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
- •progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
- •maximum diameter of the largest fibroid is greater than 4 cm
- •maximum number of uterine myomas is not to be more than 5 myomas
- •uterine fibroid may be subserous or intramural
排除标准
- •obesity (BMI >30 kg/m2)
- •cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
- •patients known to be allergic to prostaglandin preparations
- •patients who received preoperative hormonal therapy (GnRH analogue)
- •patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
- •patients with positive pregnancy test
- •virgin patients
研究组 & 干预措施
misoprostol group
Active Comparator
preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy
干预措施: preoperative vaginal misoprostol (Drug)
uterine artery ligation group
Active Comparator
bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy
干预措施: bilateral uterine artery ligation (Procedure)
结局指标
主要结局
estimated intraoperative blood loss measured in milliliters
时间窗: 60 min
次要结局
- duration of hospital stay in days(7 days)
- operative time in minutes(60 min)
- the need for conversion from myomectomy to hysterectomy(60 min)
- differance between pre and post operative hemoglobin and hematocrit levels(24 hours)
- the need of intra-operative blood transfusion(60 min)
- intraoperative or postoperative complications(24 hours)
研究者
aliaa mohamed ali
university
Ain Shams Maternity Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Methods to Reduce Blood Loss in Abdominal MyomectomyAbdominal MyomectomyBlood LossNCT04595812Cairo University120
已完成
2 期
Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office HysteroscopyPainNCT02328495Cairo University76
Unknown
1 期
Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol CreamPregnancy CervixNCT05306405Ain Shams University120
已完成
2 期
Estradiol Pretreatment With Misoprostol in Second Trimester MiscarriageMiscarriageNCT03479879Ain Shams University200
已完成
不适用
Misoprostol for Second Trimester Termination of PregnancyTermination of Pregnancy Second TrimesterNCT00945997Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)176