Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara University
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Erkan Kalafat
Medical Doctor
Ankara University