Transperineal Ultrasonography and Premature Rupture of Membranes

April 11, 2015 updated by: Erkan Kalafat, Ankara University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: PAMG-1 Immunoassay
Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
Other Names:
  • AmniSure test (AmniSure International LLC, Boston, USA)
Device: Ultrasound transperineal assessment
Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
Device: 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.
Other: Nitrazine test
To assess acid , alkaline status of pooled fluid in vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Acar F Koc, Professor, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 21, 2015

First Submitted That Met QC Criteria

March 7, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 11, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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