Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage

NCT03190434 | Completed DMC

• 3 other identifiers: F-04-13-5.4F-04-13-5.4 REV-520162402
• Study Type: observational
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief 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". 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.

Conditions

AMNIOTIC FLUID LEAKAGE

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1

Secondary Outcomes (1)

• result reading clarity

  day 1

Study Arms (1)

amniotic fluid

amniotic fluid identification by AL-SENSE product

Device: AL-SENSE

Interventions

AL-SENSE DEVICE

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.

amniotic fluid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women arriving at the hospital and reporting unidentified wetness

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Common Sense: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

vaginal fluids

Study Officials

• Amanda Black, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 16, 2017
• Study Start: May 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: June 16, 2017

Record last verified: 2006-08

Data Sharing

• IPD Sharing: Will not share