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NCT01735695 Clinical Trial

Performance Evaluation Study for a New Meconium Detection Test

Pregnancy Clinical Trial

Official title:
Performance Evaluation Study for a New Meconium Detection Test

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01735695
Other study ID # Laniado25112012
Secondary ID Laniado25122012-
Status Recruiting
Phase N/A
First received November 25, 2012
Last updated April 28, 2013
Start date December 2012
Est. completion date December 2013

Study information
Verified date April 2013
Source Laniado Hospital
Contact Brigita Weitrov, MD
Phone 972-50-8840757
Email morami12@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Laniado Hospital Natania

Sponsors (1)
Lead Sponsor Collaborator
Laniado Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Meconium concentration in amniotic fluid One year No
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