Performance Evaluation Study for a New Meconium Detection Test

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01735695

Enrollment

100

Registered

2012-11-28

Start date

2012-12-31

Completion date

2013-12-31

Last updated

2013-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Meconium, concentration, level

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Meconium concentration in amniotic fluid	One year

Countries

Israel

Contacts

Primary ContactBrigita Weitrov, MD

morami12@gmail.com972-50-8840757

Outcome results