跳至主要内容
临床试验/NCT01762319
NCT01762319Unknown不适用

Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

200 mcg Misoprostol SL 1 hour prior to fractional curettage

干预措施: Misoprostol (Drug)

Vitamin B6

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验