Amniotic ProblemsNCT03177135
PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND HOSPITAL
A study testing AmnioSense in people with Amniotic Problems, run by Common Sense.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amniotic Problems
- What is being tested?
- AmnioSense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND AS A HOSPITAL STANDARD OF CARE FOR AMNIOTIC FLUID LEAK DETECTION
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.
Read more
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.
Read the detailed description
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 wetness will be provided with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness but for no longer than 2 hours prior to a clinical assessment as per hospital standard procedure.
The clinician performing clinical diagnosis tests (clinical assessment) 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.
Clinical diagnosis of ROM and subsequent management of care will be determined as per clinicians' judgment using the standard hospital procedures of ferning and/or positive Nitrazine testing and/or sterile speculum examination.
The research team or attending nurse (non-bias to the subject's result record) will read the results of the AMNIOSENSE Blue pad, record the results in the data collection forms, and place the AMNIOSENSE Blue pad in a sealed envelope labeled with the study ID. These results will not be communicated to the attending clinicians who will remain blinded.
In each case, the subject will also be required to read and record any occurrence of color change of the AMNIOSENSE Blue 10 minutes after removing the test on the designated form.
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 participants will be provided with instructions for use and also instructed to read the Instructions For Use (IFU) prior to applying the AMNIOSENSE Blue pad. They will be instructed to only apply the AMNIOSENSE Blue pad when they are planning to attend the triage/delivery unit for assessment of wetness/leaking. 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.
Upon arrival to the triage/delivery unit, the participant and the attending nurse or research team member (non-bias to the subject's result record) will retrieve the AMNIOSENSE Blue pad and record the results in the designated data collection forms and place the AMNIOSENSE Blue pad in a sealed envelope labeled with the study ID. These results will not be communicated to the attending clinicians who will remain blinded.
In each case, the subject will also be required to read and record any occurrence of color change of the AMNIOSENSE Blue 10 minutes after removing the test on the designated form.
While in the hospital, participants will be managed according to standard hospital procedure at the discretion of the clinician and have clinical diagnostic tests (clinical assessment) for amniotic fluid leak detection, according to the hospital standard procedure. The clinician will be blinded to the results of the AMNIOSENSE Blue during the study, and as such subject treatment will be based only on the standard hospital diagnostic methods.
- Conditions
- Amniotic Problems
- Being tested
- AmnioSense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioSenseDevice
A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| AmnioSense diagnostic pantyliner | Experimental | AmnioSense diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods Receives: Device: AmnioSense |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Common Sense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Amanda, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177135
- Sponsor's protocol ID
- F-7-32.3-1
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND AS A HOSPITAL STANDARD OF CARE FOR AMNIOTIC FLUID LEAK DETECTION
- ClinicalTrials.gov ID
- NCT03177135
- Acronym / sponsor ID
- F-7-32.3-1
- Conditions
- Amniotic Problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Common SenseUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 wetness will be provided with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness but for no longer than 2 hours prior to a clinical assessment as per hospital standard procedure.
The clinician performing clinical diagnosis tests (clinical assessment) 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.
Clinical diagnosis of ROM and subsequent management of care will be determined as per clinicians' judgment using the standard hospital procedures of ferning and/or positive Nitrazine testing and/or sterile speculum examination.
The research team or attending nurse (non-bias to the subject's result record) will read the results of the AMNIOSENSE Blue pad, record the results in the data collection forms, and place the AMNIOSENSE Blue pad in a sealed envelope labeled with the study ID. These results will not be communicated to the attending clinicians who will remain blinded.
In each case, the subject will also be required to read and record any occurrence of color change of the AMNIOSENSE Blue 10 minutes after removing the test on the designated form.
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 participants will be provided with instructions for use and also instructed to read the Instructions For Use (IFU) prior to applying the AMNIOSENSE Blue pad. They will be instructed to only apply the AMNIOSENSE Blue pad when they are planning to attend the triage/delivery unit for assessment of wetness/leaking. 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.
Upon arrival to the triage/delivery unit, the participant and the attending nurse or research team member (non-bias to the subject's result record) will retrieve the AMNIOSENSE Blue pad and record the results in the designated data collection forms and place the AMNIOSENSE Blue pad in a sealed envelope labeled with the study ID. These results will not be communicated to the attending clinicians who will remain blinded.
In each case, the subject will also be required to read and record any occurrence of color change of the AMNIOSENSE Blue 10 minutes after removing the test on the designated form.
While in the hospital, participants will be managed according to standard hospital procedure at the discretion of the clinician and have clinical diagnostic tests (clinical assessment) for amniotic fluid leak detection, according to the hospital standard procedure. The clinician will be blinded to the results of the AMNIOSENSE Blue during the study, and as such subject treatment will be based only on the standard hospital diagnostic methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AmnioSense diagnostic pantyliner | Experimental | Device: AmnioSenseAmnioSense diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 and above.
- Subject minimum 26+0 weeks of pregnancy.
- Subject presents with feeling of vaginal wetness.
- Age 18 and above
- Subject minimum 36+0 weeks of pregnancy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmnioSenseA diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis. | Device | AmnioSense diagnostic pantyliner |
Primary outcome
AmnioSense performance
Time frame: 10 minutes
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Amanda, MD principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing AmnioSense in people with Amniotic Problems, run by Common Sense.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Amanda, MD (613-738-8400 ext. 81739, ablack@ottawahospital.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AmnioSense performance (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.