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

NCT02959268 | Completed

• 1 other identifier: F-7-32.4-4
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Color change of pantyliner surface compared to standard clinical diagnosis

  Color change

  10 minutes

Secondary Outcomes (2)

• Questionnaire to assess subject comprehension of usage criteria and subjective experience

  15 minutes

• Subject vs. Clinician reading of liner color change

  up to 48 hours

Study Arms (1)

Single arm Al-Sense diagnostic

OTHER

Investigator blinded to subject assessments

Device: Al-Sense

Interventions

Al-Sense DEVICE

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

Single arm Al-Sense diagnostic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Common Sense: lead

Study Sites (4)

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Rutgers Womens Health Institute

New Brunswick, New Jersey, 08901, United States

Location

University Hospital Rutgers Newark

Newark, New Jersey, 07103, United States

Location

Drexel University Medical School

Philadelphia, Pennsylvania, 19102, United States

Location

Study Officials

• Shantala Ramachandra, MD

  Consultant Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 31, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)