CompletedPhase 1/2

Pivotal Study of the Al-Sense Study Protocol

United States, Israel330 participantsStarted 2006-05

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient.

Timeframe: up to 12 hours

Trial details

NCT IDNCT00604838

SponsorWestern Galilee Hospital-Nahariya

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2006-11

View on ClinicalTrials.gov More Amniotic Fluid Leakage trials