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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hadassah Medical Organization.
Recruitment status was  Active, not recruiting
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

January 23, 2012
January 24, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01517633 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

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.

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.

Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Amniotic Fluid Leakage
Device: BirthSign
When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.
Experimental: A device for identifying between amniotic fluid and urine
Intervention: Device: BirthSign
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.
 
Active, not recruiting
100
Not Provided
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pregnant women age 18 years and older attending delivery room.
  2. Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
  3. 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:

  1. Prior use of any amniotic fluid detection test.
  2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
  3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
  4. Sexual intercourse within the past 24 hours.
  5. Confirmed diagnosis of any vaginal infection within the past 7 days.
  6. 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..
  7. Patients unable or unwilling to participate.
  8. Patients in active labor (or with regular contractions).
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01517633
300165-HMO-CTIL
Not Provided
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP