Performance Evaluation Study for a New Meconium Detection Test
- Conditions
- Pregnancy
- Registration Number
- NCT01735695
- Lead Sponsor
- Laniado Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Meconium concentration in amniotic fluid One year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Laniado Hospital
🇮🇱Natania, Israel