Amniotic Fluid LeakagePhase 2/3NCT01517633
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
A Phase 2/3 study testing BirthSign in people with Amniotic Fluid Leakage, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine. 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 Fluid Leakage
- What is being tested?
- BirthSign
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 2/3
- 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
- Pregnant women age 18 years and older attending delivery room.
- Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
- Able and willing to read and sign an informed consent document.
Who cannot join
- Subjects will be excluded from the study if any of the following will be present:
- Prior use of any amniotic fluid detection test.
- Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
- Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
- Sexual intercourse within the past 24 hours.
- Confirmed diagnosis of any vaginal infection within the past 7 days.
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- Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..
- Patients unable or unwilling to participate.
- Patients in active labor (or with regular contractions).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.
Read the detailed description
Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.
- Conditions
- Amniotic Fluid Leakage
- Being tested
- BirthSign
- Keywords
- Amniotic fluid leakage, Urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirthSignDevice
When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.
| Study group | Role | What they receive |
|---|---|---|
| A device for identifying between amniotic fluid and urine | Experimental | Not described Receives: Device: BirthSign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence / absence of stains comparing to a known color index printed on the product
Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.
Measured: 12 hours
Secondary outcomes (1)
Presence / absence of stains comparing to a known color index printed on the product
Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amniotic Fluid LeakageStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517633
- Sponsor's protocol ID
- 300165-HMO-CTIL
- Status last verified
- Jan 2012
- First submitted
- 23 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
Publications
El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X.
PubMed 20569537
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
- ClinicalTrials.gov ID
- NCT01517633
- Acronym / sponsor ID
- 300165-HMO-CTIL
- Conditions
- Amniotic Fluid Leakage
- Keywords
- Amniotic fluid leakage, Urinary incontinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- First posted
- 25 Jan 2012 (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.
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.
Detailed description
Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A device for identifying between amniotic fluid and urine | Experimental | Device: BirthSign |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women age 18 years and older attending delivery room.
- Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
- Able and willing to read and sign an informed consent document.
Key exclusion criteria (9 listed)
- Prior use of any amniotic fluid detection test.
- Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
- Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
- Sexual intercourse within the past 24 hours.
- Confirmed diagnosis of any vaginal infection within the past 7 days.
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 |
|---|---|---|
| BirthSignWhen leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids. | Device | A device for identifying between amniotic fluid and urine |
Primary outcome
Presence / absence of stains comparing to a known color index printed on the product
Time frame: 12 hours
Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.
1 secondary outcome
Presence / absence of stains comparing to a known color index printed on the product
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Background: PubMed 20569537El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BirthSign in people with Amniotic Fluid Leakage, run by Hadassah Medical Organization 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 9 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 25 Jan 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence / absence of stains comparing to a known color index printed on the product (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517633, which also lists 1 linked publication.
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 25 Jan 2012.