Back to resultsTransperineal Ultrasonography and Premature Rupture of Membranes
Primary Purpose
Preterm Premature Rupture of the Membranes
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PAMG-1 Immunoassay
Ultrasound transperineal assessment
Ultrasound amniotic fluid index measurement
Speculum examination
Nitrazine test
Sponsored by
About this trial
This is an interventional diagnostic trial for Preterm Premature Rupture of the Membranes
Eligibility Criteria
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
Sites / Locations
- Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Suspected Membrane Rupture Arm
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02386644
Brief Title
Transperineal Ultrasonography and Premature Rupture of Membranes
Official Title
Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of the Membranes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspected Membrane Rupture Arm
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
PAMG-1 Immunoassay
Other Intervention Name(s)
AmniSure test (AmniSure International LLC, Boston, USA)
Intervention Description
Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
Intervention Type
Device
Intervention Name(s)
Ultrasound transperineal assessment
Intervention Description
Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
Intervention Type
Device
Intervention Name(s)
Ultrasound amniotic fluid index measurement
Intervention Description
Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
Intervention Type
Other
Intervention Name(s)
Speculum examination
Intervention Description
Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
Intervention Type
Other
Intervention Name(s)
Nitrazine test
Intervention Description
To assess acid , alkaline status of pooled fluid in vagina.
Primary Outcome Measure Information:
Title
True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test.
Description
True positive rate and true negative rate of transperineal assessment will be calculated in percentages compared to PAMG-1 immunoassay as reference test.
Time Frame
Up to 3 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acar F Koc, Professor
Organizational Affiliation
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Transperineal Ultrasonography and Premature Rupture of Membranes
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