Transperineal Ultrasonography and Premature Rupture of Membranes

Ankara University

Status: Completed

Conditions: Preterm Premature Rupture of the Membranes

Treatments: Device: Ultrasound transperineal assessment; Device: Ultrasound amniotic fluid index measurement; Other: Speculum examination; Other: PAMG-1 Immunoassay; Other: Nitrazine test

Study type: Interventional

Funder types: Other

Identifiers

NCT02386644

002

Details and patient eligibility

About

This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment compared with speculum examination, nitrazine and placental micro globulin-1 tests.

Full 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.

Enrollment: 105 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Suspected Membrane Rupture Arm

Experimental group

Description:

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

Treatment:

Other: PAMG-1 Immunoassay

Other: Nitrazine test

Device: Ultrasound amniotic fluid index measurement

Other: Speculum examination

Device: Ultrasound transperineal assessment