Transperineal Ultrasonography and Premature Rupture of Membranes

Preterm Premature Rupture of the Membranes Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of the Membranes
• Rupture

• NCT number: NCT02386644
• Study type: Interventional
• Source: Ankara University
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Completion date: April 2015