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Completed

NCT Number: NCT02386644

Transperineal Ultrasonography and Premature Rupture of Membranes

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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Key information

Conditions

Preterm Premature Rupture of the Membranes

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAMG-1 Immunoassay

Other

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

Other names: AmniSure test (AmniSure International LLC, Boston, USA)

Ultrasound transperineal assessment

Device

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

Ultrasound amniotic fluid index measurement

Device

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

Speculum examination

Other

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

Nitrazine test

Other

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

Primary outcomes

  1. True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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