PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND HOSPITAL

NCT03177135 | Unknown

• 1 other identifier: F-7-32.3-1
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• AmnioSense performance

  The primary efficacy endpoints are: presence or absence of a blue or green stain on a yellow background as confirmed by the study team yielded by the AMNIOSENSE Blue, compared to the "hospital standard procedure" - final clinical diagnosis (positive/negative) to assess the agreement between the subject/study team reading and final clinical diagnosis, in both study group 1 (hospital usage and 2 home usage).

  10 minutes

Study Arms (1)

AmnioSense diagnostic pantyliner

EXPERIMENTAL

AmnioSense diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods

Device: AmnioSense

Interventions

AmnioSense DEVICE

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

AmnioSense diagnostic pantyliner

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1:
• Age 18 and above.
• Subject minimum 26+0 weeks of pregnancy.
• Subject presents with feeling of vaginal wetness.
• Group 2:
• Age 18 and above
• Subject minimum 36+0 weeks of pregnancy
• Subject presents with a feeling of vaginal wetness, and has applied the AMNIOSENSE Blue pad prior to arriving at the triage/delivery unit

You may not qualify if:

• Subject is unable or unwilling to comply with study procedures
• Subject with active vaginal bleeding present at the time of admission to triage
• Evidence of a non-reassuring fetal status at the time of assessment in triage (abnormal fetal heart tracing)
• Subject has reported to have had sexual intercourse within the last 12 hours

Sponsors & Collaborators

• Common Sense: lead

Study Officials

• Amanda Amanda, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Amanda, MD

CONTACT

613-738-8400; ablack@ottawahospital.on.ca

Natalie Rybak, BSc

CONTACT

613-737-8899; nrybak@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 6, 2017
• Study Start: July 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: January 30, 2018
• Last Updated: June 6, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share