Preterm Premature Rupture of the MembranesNCT02386644
Transperineal Ultrasonography and Premature Rupture of Membranes
A study testing PAMG-1 Immunoassay, Ultrasound transperineal assessment and Ultrasound amniotic fluid index measurement in people with Preterm Premature Rupture of the Membranes, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of the Membranes
- What is being tested?
- PAMG-1 Immunoassay, Ultrasound transperineal assessment and Ultrasound amniotic fluid index measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, 06100
About this study
Official title: 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.
Read the 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.
- Being tested
- PAMG-1 Immunoassay, Ultrasound transperineal assessment, Ultrasound amniotic fluid index measurement, Speculum examination, Nitrazine test
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMG-1 ImmunoassayOther
Also called AmniSure test (AmniSure International LLC, Boston, USA)
Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
Ultrasound transperineal assessmentDevice
Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
Ultrasound amniotic fluid index measurementDevice
Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
Speculum examinationOther
Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
Nitrazine testOther
To assess acid , alkaline status of pooled fluid in vagina.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Membrane Rupture Arm | Experimental | 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 Receives: Other: PAMG-1 Immunoassay; Device: Ultrasound transperineal assessment; Device: Ultrasound amniotic fluid index measurement; Other: Speculum examination; Other: Nitrazine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of the MembranesStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Kalafat, Ankara University
- Investigators
- Acar F Koc, Professor, Study director, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386644
- Sponsor's protocol ID
- 002
- Status last verified
- Apr 2015
- First submitted
- 21 Feb 2015
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Rupture of Membranes Assessment Via Transperineal Ultrasonography as an Alternative to Speculum Examinations
- ClinicalTrials.gov ID
- NCT02386644
- Acronym / sponsor ID
- 002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Membrane Rupture Arm | Experimental | Other: PAMG-1 Immunoassay, Device: Ultrasound transperineal assessment, Device: Ultrasound amniotic fluid index measurement, Other: Speculum examination, Other: Nitrazine testWomen 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAMG-1 ImmunoassayAlso: AmniSure test (AmniSure International LLC, Boston, USA)Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids. | Other | Suspected Membrane Rupture Arm |
| Ultrasound transperineal assessmentTransperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid. | Device | Suspected Membrane Rupture Arm |
| Ultrasound amniotic fluid index measurementCalculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants. | Device | Suspected Membrane Rupture Arm |
| Speculum examinationSterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling. | Other | Suspected Membrane Rupture Arm |
| Nitrazine testTo assess acid , alkaline status of pooled fluid in vagina. | Other | Suspected Membrane Rupture Arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Acar F Koc, Professor study director
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAMG-1 Immunoassay, Ultrasound transperineal assessment and Ultrasound amniotic fluid index measurement in people with Preterm Premature Rupture of the Membranes, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True positive and negative percent agreement between transperineal assessment and PAMG-1 immunoassay as reference test. (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.