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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected Membrane Rupture Arm | Experimental | Women with suspected membrane rupture will be subject to following interventions; Ultrasound amniotic fluid index measurement, ultrasound transperineal assessment, nitrazine test, speculum examination, PAMG-1 Immunoassay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAMG-1 Immunoassay | Other | Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Acar F Koc, Professor | Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology | Ankara | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
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| Ultrasound transperineal assessment | Device | Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid. |
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| Ultrasound amniotic fluid index measurement | Device | Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants. |
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| Speculum examination | Other | Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling. |
|
| Nitrazine test | Other | To assess acid , alkaline status of pooled fluid in vagina. |
|