Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT01517633

First received: January 23, 2012

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 23, 2012
Last Updated Date	January 24, 2012
Start Date ^ICMJE	January 2012
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 24, 2012)	Presence / absence of stains comparing to a known color index printed on the product [ Time Frame: 12 hours ] [ Designated as safety issue: No ] Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01517633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 24, 2012)	Presence / absence of stains comparing to a known color index printed on the product [ Time Frame: 12 hours ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Official Title ^ICMJE	Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Brief 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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Amniotic Fluid Leakage
Intervention ^ICMJE	Device: BirthSign When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.
Study Arm (s)	Experimental: A device for identifying between amniotic fluid and urine Intervention: Device: BirthSign
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):561-9. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Completion Date	Not Provided
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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. 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).
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01517633
Other Study ID Numbers ^ICMJE	300165-HMO-CTIL
Has Data Monitoring Committee	Not Provided
Responsible Party	Hadassah Medical Organization
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hadassah Medical Organization
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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