Transperineal Ultrasonography and Premature Rupture of Membranes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-04-30

Brief Summary

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

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Detailed Description

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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

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Preterm Premature Rupture of the Membranes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Suspected Membrane Rupture Arm

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

Group Type EXPERIMENTAL

PAMG-1 Immunoassay

Intervention Type OTHER

Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.

Ultrasound transperineal assessment

Intervention Type DEVICE

Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.

Ultrasound amniotic fluid index measurement

Intervention Type DEVICE

Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.

Speculum examination

Intervention Type OTHER

Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.

Nitrazine test

Intervention Type OTHER

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

Interventions

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PAMG-1 Immunoassay

Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.

Intervention Type OTHER

Ultrasound transperineal assessment

Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.

Intervention Type DEVICE

Ultrasound amniotic fluid index measurement

Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.

Intervention Type DEVICE

Speculum examination

Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.

Intervention Type OTHER

Nitrazine test

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

Intervention Type OTHER

Other Intervention Names

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AmniSure test (AmniSure International LLC, Boston, USA)

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes