Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 主要终点
- accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy
研究概览
简要总结
Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients who have no history of hysteroscopy and curettage,
- •patients who have no history of ovulatory dysfunction
- •women who have active vaginal bleeding.
排除标准
- •presence of genital infections/PID
- •presence of pregnancy
- •presence of vaginal or cervical pathology causing vaginal bleeding
- •women who are receiving hormonal treatment (COC/HRT)
- •patients formerly diagnosed with endometrial pathology
- •patients having coagulopathy
- •women who are using intrauterine device.
研究组 & 干预措施
Transvaginal ultrasound
Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.
干预措施: Transvaginal ultrasound (Device)
Hysteroscopy
Hysteroscopy was also performed under general anesthesia.Hysteroscopy was performed by a single operator (NNY).The operator and two supervising endoscopists were blinded to the ultrasound results.After the hysteroscopy, endometrial sampling was also done. The diagnoses were compared with the received endometrial samples.
干预措施: Hysteroscopy (Device)
结局指标
主要结局
accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy
时间窗: up to 12 month
The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .
次要结局
未报告次要终点
研究者
Nazlı YENIGUL
Principal Investigator MD
Sisli Hamidiye Etfal Training and Research Hospital