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Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening

NCT02959268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2019-10-31

No results posted yet for this study

Summary

This is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments. Pregnant women 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.

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 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. A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment). The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test and/or positive results in both the pH test and the Ferning test will be defined as a positive clinical test result.

Conditions

  • Amniotic Problems

Interventions

DEVICE

Al-Sense

Liner for diagnosis of amniotic fluid leakage verified by standard clinical diagnostic tests

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Principal Investigators

  • Shantala Ramachandra, MD · Consultant Medical Monitor

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02959268 on ClinicalTrials.gov