The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester
研究概览
简要总结
The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.
详细描述
All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The performer of the hysteroscopy will not be aware of the result of the ultrasound exam
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women .
- •Clinical diagnosis of first trimester spontaneous abortion.
排除标准
- •viable pregnancy
- •women below 18 years
- •women with chronic disease
结局指标
主要结局
The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester
时间窗: up to 12 weeks
Transabdominal ultrasonography detection of gestational sac insertion location will be compared with gestational sac location diagnosed with hysteroscopy.
次要结局
未报告次要终点
研究者
Assaf Harofeh MC
Doctor
Assaf-Harofeh Medical Center