NCT02386644

Transperineal Ultrasonography and Premature Rupture of Membranes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Premature Rupture of the Membranes

Interventions

Type	Name	Description
OTHER	PAMG-1 Immunoassay	Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
DEVICE	Ultrasound transperineal assessment	Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
DEVICE	Ultrasound amniotic fluid index measurement	Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
OTHER	Speculum examination	Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
OTHER	Nitrazine test	To assess acid , alkaline status of pooled fluid in vagina.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-03-12
• Last updated: 2015-04-14

Locations

1 site across 1 country: Turkey (Türkiye)