Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding
研究概览
简要总结
Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic procedure of this condition. Traditionally, fractional curettage is performed under local anesthesia such as paracervical nerve block or intravenous meperidine.
Cervical dilatation using "metal cervical dilator" is a common method prior to perform fractional curettage. However, complication from this procedure can be occurred frequently, for example, uterine perforation, false tract formation and laceration of cervix.
Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and gynecology. Misoprostol transforms cervical component causing cervical ripening. This is very helpful for transcervical procedure because cervical dilatation is usually omitted. It can be prescribed in many route and sublingual route is the most effectiveness. Moreover, WHO supports the use of misoprostol in obstetrics and gynecology practice.
The hypothesis of this study is that "Misoprostol 200 micrograms sublingually is effective for cervical ripening before performing fractional curettage in patients with abnormal uterine bleeding" Double blind randomised controlled trial was performed using 26 patients in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •thai women at the age over 35 years old
- •presenting with abnormal uterine bleeding and have a plan to perform fractional curettage
排除标准
- •uterine anomalies
- •pregnancy
- •pelvic inflammatory disease
- •uncontrolled medical or psychological conditions
- •known cases of gynecological diseases such as gynecological malignancies, abnormal pap smear
- •Prostaglandin allergy
- •Contraindicate to prostaglandin: asthma, mitral valve stenosis, glaucoma, sickle cell anemia
研究组 & 干预措施
Misoprostol
200 mcg Misoprostol SL 1 hour prior to fractional curettage
干预措施: Misoprostol (Drug)
Vitamin B6
100 mg Vitamin B6 SL 1 hr prior to fractional curettage
干预措施: Vitamin B6 (Drug)
结局指标
主要结局
efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding
时间窗: 1 Year
an efficacy of sublingual misoprostol in this study was dilatation of uterine cervix which was measured by a diameter of MVA cannula in millimeters.
次要结局
未报告次要终点
