Transperineal Ultrasonography and Premature Rupture of Membranes

Not Applicable

Completed

• Conditions: Preterm Premature Rupture of the Membranes
• Interventions: Other: PAMG-1 Immunoassay; Device: Ultrasound transperineal assessment; Device: Ultrasound amniotic fluid index measurement; Other: Speculum examination; Other: Nitrazine test

• Registration Number: NCT02386644
• Lead Sponsor: Ankara University

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-21
• Study First Submitted QC: 2015-03-07
• Study First Posted: 2015-03-12
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-11
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suspected Membrane Rupture Arm	Speculum examination	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
Suspected Membrane Rupture Arm	Nitrazine test	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
Suspected Membrane Rupture Arm	Ultrasound transperineal assessment	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
Suspected Membrane Rupture Arm	PAMG-1 Immunoassay	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
Suspected Membrane Rupture Arm	Ultrasound amniotic fluid index measurement	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology; 🇹🇷 Ankara, Turkey