Amniotic ProblemsPhase 3NCT02965430
PERFORMANCE STUDY OF THE AL-SENSE
A Phase 3 study testing AL-SENSE in people with Amniotic Problems, run by Common Sense.
Trial summary
This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amniotic Problems
- What is being tested?
- AL-SENSE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Apr 2017
- Phase
- Phase 3
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 years or greater.
- Subject minimum 16 weeks of pregnancy.
- Who will sign the informed consent form.
- Who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence).
Who cannot join
- Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimesters.
- Subjects that have had sexual intercourse within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
About this study
This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence.
Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any wetness.
The blinded physician will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.
Read the detailed description
This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence. Subjects arriving at the hospital and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE.
In each case, the blinded clinician will be required to read and record any occurrence of color change of the AL-SENSE 10 minutes after the AL-SENSE removal and to mark if it changes color to blue or to green on the designated form.
The blinded physician (other than the clinician who records the AL-SENSE results) will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.
In cases where the AL-SENSE shows positive results but the clinical assessment results are negative, reference laboratories, or any other standard procedure will check for the possibility of BV or Trichomonas in addition to the tests noted above.
- Conditions
- Amniotic Problems
- Being tested
- AL-SENSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-SENSEDevice
A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis
| Study group | Role | What they receive |
|---|---|---|
| AL-SENSE diagnostic pantyliner | Experimental | AL-SENSE diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods. Receives: Device: AL-SENSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
color change of the pantyliner in comparison to standard clinical diagnosis
presence or absence of a blue or green stain on a yellow background as observed by the clinician yielded by the AL-SENSE in addition to the binary clinical diagnosis
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic ProblemsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Common Sense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965430
- Sponsor's protocol ID
- F-7-32.4-5.1
- Status last verified
- Dec 2017
- First submitted
- 14 Nov 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERFORMANCE STUDY OF THE AL-SENSE
- ClinicalTrials.gov ID
- NCT02965430
- Acronym / sponsor ID
- F-7-32.4-5.1
- Conditions
- Amniotic Problems
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Common SenseUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Nov 2016 (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 is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence.
Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any wetness.
The blinded physician will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.
Detailed description
This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence. Subjects arriving at the hospital and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE.
In each case, the blinded clinician will be required to read and record any occurrence of color change of the AL-SENSE 10 minutes after the AL-SENSE removal and to mark if it changes color to blue or to green on the designated form.
The blinded physician (other than the clinician who records the AL-SENSE results) will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.
In cases where the AL-SENSE shows positive results but the clinical assessment results are negative, reference laboratories, or any other standard procedure will check for the possibility of BV or Trichomonas in addition to the tests noted above.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL-SENSE diagnostic pantyliner | Experimental | Device: AL-SENSEAL-SENSE diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 years or greater.
- Subject minimum 16 weeks of pregnancy.
- Who will sign the informed consent form.
- Who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence).
Key exclusion criteria (4 listed)
- Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimesters.
- Subjects that have had sexual intercourse within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
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 |
|---|---|---|
| AL-SENSEA diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis | Device | AL-SENSE diagnostic pantyliner |
Primary outcome
color change of the pantyliner in comparison to standard clinical diagnosis
Time frame: 10 min
presence or absence of a blue or green stain on a yellow background as observed by the clinician yielded by the AL-SENSE in addition to the binary clinical diagnosis
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 4 Sep 2019.
- Individual participant dataSharing planned: No
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.
Liangkun Ma, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL-SENSE in people with Amniotic Problems, run by Common Sense.
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 4 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
color change of the pantyliner in comparison to standard clinical diagnosis (time frame: 10 min). 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 4 Sep 2019.