Transperineal Ultrasonography and Premature Rupture of Membranes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations

Conditions
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Preterm Premature Rupture of the Membranes

Intervention / Treatment
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* Other: PAMG-1 Immunoassay
* Device: Ultrasound transperineal assessment
* Device: Ultrasound amniotic fluid index measurement
* Other: Speculum examination
* Other: Nitrazine test


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspected Membrane Rupture Arm<br>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 | Other: PAMG-1 Immunoassay<br>* Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.<br>* Other names: AmniSure test (AmniSure International LLC, Boston, USA);Device: Ultrasound transperineal assessment<br>* Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.<br>Device: Ultrasound amniotic fluid index measurement<br>* Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.<br>Other: Speculum examination<br>* Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.<br>Other: Nitrazine test<br>* To assess acid , alkaline status of pooled fluid in vagina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |