This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment compared with speculum examination, nitrazine and placental micro globulin-1 tests.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
105
Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, Turkey (Türkiye)
True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
True positive rate and true negative rate of transperineal assessment will be calculated in percentages compared to PAMG-1 immunoassay as reference test.
Time frame: Up to 3 months
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Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
To assess acid , alkaline status of pooled fluid in vagina.