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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386644
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: February 21, 2015
• Last updated: April 11, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Intervention

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.
• 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.
• Nitrazine test
To assess acid , alkaline status of pooled fluid in vagina.

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No