Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
研究概览
简要总结
This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment compared with speculum examination, nitrazine and placental micro globulin-1 tests.
详细描述
Women with early and late preterm pregnancies with a complaint of fluid leakage are enrolled in the study. Prior to speculum examination, sagittal view of the birth canal and transverse view of cervix and fornices are obtained with transperineal technique and images are stored. Then speculum examination for pooling, nitrazine test and placental microglobulin-1 tests are performed and results are recorded. Ultrasound images are analysed by an observer blind to physical examination findings. Hypoechogenic fluid appearance of adequate size around the cervix and in the fornices are considered positive. Placental microglobulin-1 test is used as reference. Sensitivity and specificity values are calculated for each test.
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
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with early and late preterm pregnancies, (i.e., women above 24th and below 37th week of gestation)
- •Pregnant women with a complaint of fluid leakage
排除标准
- •Women with term pregnancies (i.e., women above 37th week of gestation)
- •Women with unviable pregnancies (i.e., women below 24th week of gestation)
- •Women in active labor (i.e., cervical dilatation above 4cm during admission)
- •Women with vaginal bleeding
结局指标
主要结局
True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
时间窗: Up to 3 months
True positive rate and true negative rate of transperineal assessment will be calculated in percentages compared to PAMG-1 immunoassay as reference test.
次要结局
未报告次要终点
研究者
Erkan Kalafat
Medical Doctor
Ankara University