Amniotic Fluid LeakagePhase 1/2NCT00604838
Pivotal Study of the Al-Sense Study Protocol
A Phase 1/2 study testing AL-SENSE Diagnostic Absorbent Panty liner in people with Amniotic Fluid Leakage, run by Western Galilee Hospital-Nahariya at 2 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Amniotic Fluid Leakage
- What is being tested?
- AL-SENSE Diagnostic Absorbent Panty liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to Nov 2006
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- age 18 to 45 years.
- minimum 16 weeks of pregnancy.
- willing to sign the informed consent form.
- arrived at the obstetric department reporting a feeling of vaginal wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence).
Who cannot join
- experienced intermittent vaginal bleeding between the 2nd and 3rd trimester.
- have had sexual relations within the last 12 hours.
- unable or unwilling to cooperate with study procedures.
- used the AL-SENSE before joining this study.
- diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
- uses vaginal products such as some douching formulas, some antibiotic treatments which reduce lactobacillus population.
- uses drugs which reduce estrogen level such as tamoxifen or drugs that dry out the mucous membranes, such as antihistamines
- on a diet of alkalizing foods such as Alkalive™ Green, which may cause elevation of the vaginal pH level.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Wayne State University / Hutzel Women's Hospital
Detroit, Michigan, 48201
About this study
Official title: Pivotal Study of the Al-ASense Study Protocol
The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.
- Conditions
- Amniotic Fluid Leakage
- Being tested
- AL-SENSE Diagnostic Absorbent Panty liner
- Keywords
- amniotic fluid leakage, urinary incontinence, pregnancy, home test, vaginal wetness
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-SENSE Diagnostic Absorbent Panty linerDevice
Also called AL-SENSE Amniotic Leak Test Kit
worn for 12 hours
AL-SENSE Diagnostic Absorbent Panty linerDevice
Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Device: AL-SENSE Diagnostic Absorbent Panty liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient.
Measured: up to 12 hours
Secondary outcomes (1)
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.
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- 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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Investigators
- Jacob Bornstein, MD, Principal investigator, Western Galilee Hospital-NahariyaYoram Sorokin, MD, Principal investigator, Wayne State University / Hutzel Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604838
- Sponsor's protocol ID
- AlSense-Pivot101
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Watanabe T, Minakami H, Itoi H, Sato I, Sakata Y, Tamada T. Evaluation of latex agglutination test for alpha-fetoprotein in diagnosing rupture of fetal membranes. Gynecol Obstet Invest. 1995;39(1):15-8. doi: 10.1159/000292368.
PubMed 7534254Garite TJ, Gocke SE. Diagnosis of preterm rupture of membranes: is testing for alpha-fetoprotein better than ferning or nitrazine? Am J Perinatol. 1990 Jul;7(3):276-8. doi: 10.1055/s-2007-999500.
PubMed 1695510Kishida T, Yamada H, Negishi H, Sagawa T, Makinoda S, Fujimoto S. Diagnosis of preterm premature rupture of the membranes using a newly developed AFP monoclonal antibody test kit. Eur J Obstet Gynecol Reprod Biol. 1995 Jan;58(1):67-72. doi: 10.1016/0028-2243(94)01973-b.
PubMed 7538939Rochelson BL, Rodke G, White R, Bracero L, Baker DA. A rapid colorimetric AFP monoclonal antibody test for the diagnosis of preterm rupture of the membranes. Obstet Gynecol. 1987 Feb;69(2):163-6.
PubMed 2433650
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Al-ASense Study Protocol
- ClinicalTrials.gov ID
- NCT00604838
- Acronym / sponsor ID
- AlSense-Pivot101
- Conditions
- Amniotic Fluid Leakage
- Keywords
- amniotic fluid leakage, urinary incontinence, pregnancy, home test, vaginal wetness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- May 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 30 Jan 2008 (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.
The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: AL-SENSE Diagnostic Absorbent Panty liner |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18 to 45 years.
- minimum 16 weeks of pregnancy.
- willing to sign the informed consent form.
- arrived at the obstetric department reporting a feeling of vaginal wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence).
Key exclusion criteria (8 listed)
- experienced intermittent vaginal bleeding between the 2nd and 3rd trimester.
- have had sexual relations within the last 12 hours.
- unable or unwilling to cooperate with study procedures.
- used the AL-SENSE before joining this study.
- 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-SENSE Diagnostic Absorbent Panty linerAlso: AL-SENSE Amniotic Leak Test Kitworn for 12 hours | Device | I |
| AL-SENSE Diagnostic Absorbent Panty linerDiagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours | Device | I |
Primary outcome
presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient.
Time frame: up to 12 hours
1 secondary outcome
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.
Time frame: up to 12 hours
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 30 Jan 2008.
- Background: PubMed 7534254Watanabe T, Minakami H, Itoi H, Sato I, Sakata Y, Tamada T. Evaluation of latex agglutination test for alpha-fetoprotein in diagnosing rupture of fetal membranes. Gynecol Obstet Invest. 1995;39(1):15-8. doi: 10.1159/000292368.
- Background: PubMed 1695510Garite TJ, Gocke SE. Diagnosis of preterm rupture of membranes: is testing for alpha-fetoprotein better than ferning or nitrazine? Am J Perinatol. 1990 Jul;7(3):276-8. doi: 10.1055/s-2007-999500.
- Background: PubMed 7538939Kishida T, Yamada H, Negishi H, Sagawa T, Makinoda S, Fujimoto S. Diagnosis of preterm premature rupture of the membranes using a newly developed AFP monoclonal antibody test kit. Eur J Obstet Gynecol Reprod Biol. 1995 Jan;58(1):67-72. doi: 10.1016/0028-2243(94)01973-b.
- Background: PubMed 2433650Rochelson BL, Rodke G, White R, Bracero L, Baker DA. A rapid colorimetric AFP monoclonal antibody test for the diagnosis of preterm rupture of the membranes. Obstet Gynecol. 1987 Feb;69(2):163-6.
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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.
Jacob Bornstein, MD principal investigator
Western Galilee Hospital-Nahariya
Yoram Sorokin, MD principal investigator
Wayne State University / Hutzel Women's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AL-SENSE Diagnostic Absorbent Panty liner in people with Amniotic Fluid Leakage, run by Western Galilee Hospital-Nahariya at 2 sites in 2 countries.
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 8 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 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient. (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00604838, which also lists 4 linked publications.
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 30 Jan 2008.