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PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND HOSPITAL

NCT03177135 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-06-06

No results posted yet for this study

Summary

This is a Prospective study to demonstrate that the AMNIOSENSE Blue pad can reliably rule in or rule out amniotic fluid leak as a cause of vaginal wetness in pregnancy, thus, can be adopted by hospitals as an amniotic fluid leak detection tool, and can be recommended by care providers for use in a home usage setting.

Study Group 1: Women attending the triage / delivery room with unidentified will be provided with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness prior to a clinical assessment as per hospital standard procedure.

The clinician performing clinical diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure will be at all times blinded to the results of the AMNIOSENSE Blue pad.

Study Group 2: Women attending the obstetrical antenatal clinic for a routine antenatal visit \> 36+0, and has not been referred for further assessment in triage/delivery unit by the physician will recruited to this study group (Study Group 2). Before leaving the antenatal clinic, they will be given one AMNIOSENSE Blue pad to use at home when vaginal wetness is experienced or in any case when they suspect that they have amniotic fluid leakage. The participant will be instructed to arrive at the hospital within 2 hours of applying the AMNIOSENSE Blue pad, regardless of the test results (positive or negative), to have a clinical diagnosis by the attending physician.

Conditions

  • Amniotic Problems

Interventions

DEVICE

AmnioSense

A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis.

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Principal Investigators

  • Amanda Amanda, MD · Ottawa Hospital Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-12-30
Completion
2018-01-30

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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 NCT03177135 on ClinicalTrials.gov