Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-SENSE Diagnostic Absorbent Panty liner | Device | worn for 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient. | up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacob Bornstein, MD | Western Galilee Hospital-Nahariya | Principal Investigator |
| Yoram Sorokin, MD | Wayne State University / Hutzel Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University / Hutzel Women's Hospital | Detroit | Michigan | 48201 | United States | ||
| Western Galilee Hospital-Nahariya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7534254 | Background | 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. | |
| 1695510 | Background | Garite 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AL-SENSE Diagnostic Absorbent Panty liner | Device | Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours |
|
| Nahariya |
| 22100 |
| Israel |
| 7538939 | Background | Kishida 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. |
| 2433650 | Background | Rochelson 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |