Performance Evaluation Study for a New Meconium Detection Test

This study is currently recruiting participants.
Verified April 2013 by Laniado Hospital
Sponsor:
Information provided by (Responsible Party):
Laniado Hospital
ClinicalTrials.gov Identifier:
NCT01735695
First received: November 25, 2012
Last updated: April 28, 2013
Last verified: April 2013

November 25, 2012
April 28, 2013
December 2012
August 2013   (final data collection date for primary outcome measure)
Meconium concentration in amniotic fluid [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01735695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Performance Evaluation Study for a New Meconium Detection Test
Performance Evaluation Study for a New Meconium Detection Test

The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.

Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally.

Meconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Pregnant women

Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provide written or oral informed consent to participate in the study and agree to comply with study procedures.
  • Pregnant.
  • Intend to seek medical care during pregnancy.

Exclusion Criteria:

  • Amniotic fluid samples are mixed with urine.
Female
18 Years to 50 Years
Yes
Contact: Brigita Weitrov, MD 972-50-8840757 morami12@gmail.com
Israel
 
NCT01735695
Laniado25112012, Laniado25122012-1
No
Laniado Hospital
Laniado Hospital
Not Provided
Study Director: Brigita Wintrov, MD Laniado Medical Center
Laniado Hospital
April 2013

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