PREMATURE RUPTURE OF MEMBRANESROMNCT01804348
AL-SENSE 1-Step - Determination of Product Specificity
A study testing AL-SENSE 1-Step in people with PREMATURE RUPTURE OF MEMBRANES, run by Common Sense at 1 site in Israel.
Trial summary
Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PREMATURE RUPTURE OF MEMBRANES
- What is being tested?
- AL-SENSE 1-Step
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Aug 2013
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- AgE 18 years OR GREATER.
- Subject who will sign the informed consent form.
- Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).
Who cannot join
- Subjects that have had sexual relations within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject is currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Western Galilee Hospital
Nahariya
Jacob Bornstein, MD, +972-4-9107720, Jacob.Bornstein@naharia.health.gov.il
Jacob Bornstein, MD
About this study
Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).
Read the detailed description
Pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE 1-Step and how to read the result.
In each case, the subject and the clinician/midwife (non bias to the hospital standard procedure results) will be required to read and record any occurrence of color change of the AL-SENSE 1-Step immediately after removing the test to mark if it changes color to blue or to green or to grey on the designated form.
The non bias physician, who is not aware to the AL-SENSE 1-Step result (other than the clinician/midwife who records the AL-SENSE 1-Step results) will perform a diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure.
The investigator will compare the AL-SENSE 1-Step results reading of the patient to the clinical diagnosis.
- Conditions
- PREMATURE RUPTURE OF MEMBRANES
- Being tested
- AL-SENSE 1-Step
- Keywords
- PROM
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-SENSE 1-StepDevice
a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.
| Study group | Role | What they receive |
|---|---|---|
| AL-SENSE 1-Step | Experimental | a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. Receives: Device: AL-SENSE 1-Step |
What is being measured
The primary outcome is the main question the study is designed to answer.
amniotic fluid leaks
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREMATURE RUPTURE OF MEMBRANESStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Common Sense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Bornstain, MD, Principal investigator, Western Galilee Hospital Nahariya, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804348
- Sponsor's protocol ID
- F-7-32.2-1
- Other IDs
- 0096-12-NHR
- Acronym
- ROM
- Status last verified
- Nov 2012
- First submitted
- 19 Feb 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AL-SENSE 1-Step - Determination of Product Specificity
- ClinicalTrials.gov ID
- NCT01804348
- Acronym / sponsor ID
- ROM / F-7-32.2-1
- Conditions
- PREMATURE RUPTURE OF MEMBRANES
- Keywords
- PROM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Common SenseUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 5 Mar 2013 (estimated)
- 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.
Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).
Detailed description
Pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE 1-Step and how to read the result.
In each case, the subject and the clinician/midwife (non bias to the hospital standard procedure results) will be required to read and record any occurrence of color change of the AL-SENSE 1-Step immediately after removing the test to mark if it changes color to blue or to green or to grey on the designated form.
The non bias physician, who is not aware to the AL-SENSE 1-Step result (other than the clinician/midwife who records the AL-SENSE 1-Step results) will perform a diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure.
The investigator will compare the AL-SENSE 1-Step results reading of the patient to the clinical diagnosis.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL-SENSE 1-Step | Experimental | Device: AL-SENSE 1-Stepa single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- AgE 18 years OR GREATER.
- Subject who will sign the informed consent form.
- Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).
Key exclusion criteria (3 listed)
- Subjects that have had sexual relations within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject is currently participating in another clinical study
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 |
|---|---|---|
| AL-SENSE 1-Stepa single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. | Device | AL-SENSE 1-Step |
Primary outcome
amniotic fluid leaks
Time frame: up to 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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.
Jacob Bornstain, MD principal investigator
Western Galilee Hospital Nahariya, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AL-SENSE 1-Step in people with PREMATURE RUPTURE OF MEMBRANES, run by Common Sense at 1 site in Israel.
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 3 inclusion and 3 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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amniotic fluid leaks (time frame: up to 12 hours). 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 5 Mar 2013.