Transperineal Ultrasonography and Premature Rupture of Membranes
Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 21, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 14, 2015
April 1, 2015
2 months
February 21, 2015
April 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 3 months
Study Arms (1)
Suspected Membrane Rupture Arm
EXPERIMENTALWomen 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
Interventions
Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
To assess acid , alkaline status of pooled fluid in vagina.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Acar F Koc, Professor
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 21, 2015
First Posted
March 12, 2015
Study Start
February 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 14, 2015
Record last verified: 2015-04