Preterm Premature Rupture of the Membranes
Conditions
Brief summary
This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment compared with speculum examination, nitrazine and placental micro globulin-1 tests.
Detailed description
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.
Interventions
OTHERPAMG-1 Immunoassay
Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
DEVICEUltrasound transperineal assessment
Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
DEVICEUltrasound amniotic fluid index measurement
Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
OTHERSpeculum examination
Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
OTHERNitrazine test
To assess acid , alkaline status of pooled fluid in vagina.
Sponsors
Ankara University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test. | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed