Performance Evaluation Study for a New Meconium Detection Test

Laniado Hospital

Status: Unknown

Conditions: Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT01735695

Laniado25112012

Laniado25122012-1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.