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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Performance Evaluation Study for a New Meconium Detection Test|
- Meconium concentration in amniotic fluid [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
|Contact: Brigita Weitrov, MDfirstname.lastname@example.org|
|Contact: Birgita Weintrov, MD|
|Principal Investigator: Brigita Weintrov, MD|
|Study Director:||Brigita Wintrov, MD||Laniado Medical Center|