AMNIOTIC FLUID LEAKAGENCT03190434
Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage
An observational study of AMNIOTIC FLUID LEAKAGE, run by Common Sense.
Trial summary
This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage or a "water breaking". Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- AMNIOTIC FLUID LEAKAGE
- What is being tested?
- AL-SENSE
- Type of treatment
- Medical device
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Nov 2006
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women arriving at the hospital and reporting unidentified wetness
Who may be able to join
- Age 18 years and 45 years.
- 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 trimester.
- Subjects that have had sexual relations within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject used the AL-SENSE before joining this study.
- Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
- Subject using vaginal products such as some douching formulas, some antibiotic treatments which reduce lactobacillus population.
About this study
This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage or a "water breaking". The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness. An additional, secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and specificity that are comparable to those specified for the currently marketed AMNIOTESTTM (nitrazine yellow swabs; PRO LAB Diagnostics) product.
Read the detailed description
Baseline/ Screening
Potential subjects may undergo the informed consent process in the outpatient clinic.
Subjects attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness. The clinician will explain the proper use and handling of the AL-SENSE and how to read the result. The participants will be provided with instructions for use and also directed to read the Instructions For Use (IFU) prior to applying the AL-SENSE pad.
Product Usage After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal and to mark if it changes color to blue or to green or not on the designated form.. The used liner will be placed in a separate sealed envelope with the subject's ID and product name and protocol number on the outside.
The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension. The completed form will be placed in a sealed envelope with the subject's initials and study number on the outside.
Clinical Diagnosis A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment), and record the results on a worksheet to be included in the case report form. The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) Nitrazine paper or pH paper test. A positive Pooling test and/or positive results in both the Nitrazine or pH test and the Ferning test will be defined as a positive clinical test result for amniotic fluid.
Although the preferred sequence is using the liner before clinical diagnosis, diagnostic procedures may be done before liner use, as long as lubricants are not used for procedures. The use of lubricants interferes with the accuracy of liner reaction to amniotic fluid.
If the liner is removed for clinical testing before sufficient fluid has collected, it may either be reused or a fresh liner may be dispensed. Note that any use of lubricants contraindicates further usage of Al-Sense.
The subject is expected to remain at the hospital for the duration of the test for completing the "standard clinical diagnosis" tests, required by the protocol.
A positive Pooling test or positive results in the other 2 tests is defined as a positive clinical assessment.
Although the performance of the AL-SENSE is examined in this study, subject treatment will be based only on the standard hospital diagnostic methods.
- Conditions
- AMNIOTIC FLUID LEAKAGE
- 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
The AL-SENSE reacts differently when in contact with amniotic fluid than it does with urine. The indicator changes color to blue-green and fades back to yellow in case of urine and changes to stable blue-green in case of amniotic fluid.
| Study group | Role | What they receive |
|---|---|---|
| amniotic fluid | amniotic fluid identification by AL-SENSE product Receives: Device: AL-SENSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
amniotic fluid leakage
The primary efficacy endpoints are: presence or absence of a blue- green stain on a yellow background as observed by the subject yielded by the AL-SENSE in addition to the binary clinical diagnosis (positive/negative), in order to assess the sensitivity and specificity of the AL-SENSE versus the standard clinical diagnosis.
Measured: day 1
Secondary outcomes (1)
result reading clarity
The secondary endpoints of this study are: presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the clinician and a measurement of patient comfort while using AL-SENSE and reading the results. This will help demonstrate the ability of the subject to accurately interpret the AL-SENSE test results.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study startMay 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMNIOTIC FLUID LEAKAGEStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Common Sense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Black, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190434
- Sponsor's protocol ID
- F-04-13-5.4
- Other IDs
- F-04-13-5.4 REV-5, 20162402
- Status last verified
- Aug 2006
- First submitted
- 5 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage
- ClinicalTrials.gov ID
- NCT03190434
- Acronym / sponsor ID
- F-04-13-5.4
- Conditions
- AMNIOTIC FLUID LEAKAGE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Common SenseUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 16 Jun 2017 (actual)
- 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 is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage or a "water breaking". The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness. An additional, secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and specificity that are comparable to those specified for the currently marketed AMNIOTESTTM (nitrazine yellow swabs; PRO LAB Diagnostics) product.
Detailed description
Baseline/ Screening
Potential subjects may undergo the informed consent process in the outpatient clinic.
Subjects attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness. The clinician will explain the proper use and handling of the AL-SENSE and how to read the result. The participants will be provided with instructions for use and also directed to read the Instructions For Use (IFU) prior to applying the AL-SENSE pad.
Product Usage After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal and to mark if it changes color to blue or to green or not on the designated form.. The used liner will be placed in a separate sealed envelope with the subject's ID and product name and protocol number on the outside.
The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension. The completed form will be placed in a sealed envelope with the subject's initials and study number on the outside.
Clinical Diagnosis A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment), and record the results on a worksheet to be included in the case report form. The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) Nitrazine paper or pH paper test. A positive Pooling test and/or positive results in both the Nitrazine or pH test and the Ferning test will be defined as a positive clinical test result for amniotic fluid.
Although the preferred sequence is using the liner before clinical diagnosis, diagnostic procedures may be done before liner use, as long as lubricants are not used for procedures. The use of lubricants interferes with the accuracy of liner reaction to amniotic fluid.
If the liner is removed for clinical testing before sufficient fluid has collected, it may either be reused or a fresh liner may be dispensed. Note that any use of lubricants contraindicates further usage of Al-Sense.
The subject is expected to remain at the hospital for the duration of the test for completing the "standard clinical diagnosis" tests, required by the protocol.
A positive Pooling test or positive results in the other 2 tests is defined as a positive clinical assessment.
Although the performance of the AL-SENSE is examined in this study, subject treatment will be based only on the standard hospital diagnostic methods.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amniotic fluid | – | Device: AL-SENSEamniotic fluid identification by AL-SENSE product |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women arriving at the hospital and reporting unidentified wetness
Key inclusion criteria (4 listed)
- Age 18 years and 45 years.
- 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 (6 listed)
- Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimester.
- Subjects that have had sexual relations within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject used the AL-SENSE before joining this study.
- 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-SENSEThe AL-SENSE reacts differently when in contact with amniotic fluid than it does with urine. The indicator changes color to blue-green and fades back to yellow in case of urine and changes to stable blue-green in case of amniotic fluid. | Device | amniotic fluid |
Primary outcome
amniotic fluid leakage
Time frame: day 1
The primary efficacy endpoints are: presence or absence of a blue- green stain on a yellow background as observed by the subject yielded by the AL-SENSE in addition to the binary clinical diagnosis (positive/negative), in order to assess the sensitivity and specificity of the AL-SENSE versus the standard clinical diagnosis.
1 secondary outcome
result reading clarity
Time frame: day 1
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 16 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Amanda Black, MD principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of AMNIOTIC FLUID LEAKAGE, 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 6 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 16 Jun 2017. 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.
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?
amniotic fluid leakage (time frame: day 1). 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 16 Jun 2017.