Comparative study of 3D ultrasonography with hysteroscopy for the evaluation of uterine cavity in women with recurrent pregnancy loss and infertility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of 3D ultrasonography in comparison to hysteroscopy (sensitivity, specificity, PPV, NPV) for detection of uterine abnormalities.
研究概览
简要总结
This thesis protocol aims to compare the diagnostic efficacy of 3D transvaginal ultrasonography with diagnostic hysteroscopy in the evaluation of uterine abnormalities contributing to recurrent pregnancy loss and infertility. Conducted as a prospective comparative study at Kasturba Hospital, Delhi, it involves 39 women undergoing 3D TVS followed by hysteroscopy. 3D transvaginal ultrasonography, a less invasive technique is hypothesised to have diagnostic accuracy comparable to hysteroscopy in detecting uterine abnormalities in women with recurrent pregnancy loss and infertility. With ethical approval secured, this research seeks to help clinical decision making and optimise the diagnostic approach for women experiencing reproductive failure.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of age group more than 18 years, who have had 2 or more spontaneous, consecutive pregnancy losses in the first 20 weeks of gestation or are unable to achieve pregnancy despite 1 year of regular, unprotected sexual intercourse with husband.
排除标准
- •Pregnant women Active pelvic inflammatory disease Undiagnosed excessive uterine bleeding Bleeding disorders or any coagulation defect, Cancer of genital tract Vaginismus Any medical condition making patient unfit for anesthesia Contraindication to hysteroscopy or transvaginal ultrasound.
结局指标
主要结局
Diagnostic accuracy of 3D ultrasonography in comparison to hysteroscopy (sensitivity, specificity, PPV, NPV) for detection of uterine abnormalities.
时间窗: At baseline when 3D ultrasound is done, and then at 2 weeks when hysteroscopy is done postmenstrually
次要结局
- Detection rate of uterine abnormalities & intracavitary lesions by each method,(Types of congenital & acquired uterine abnormalities identified by each modality,)
研究者
Dr Nishtha Goel
Kasturba Hospital Delhi