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Performance Evaluation Study for a New Meconium Detection Test

This study is currently recruiting participants.
Verified April 2013 by Laniado Hospital
Sponsor:
Information provided by (Responsible Party):
Laniado Hospital
ClinicalTrials.gov Identifier:
NCT01735695
First received: November 25, 2012
Last updated: April 28, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance Evaluation Study for a New Meconium Detection Test

Further study details as provided by Laniado Hospital:

Primary Outcome Measures:
  • Meconium concentration in amniotic fluid [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735695

Contacts
Contact: Brigita Weitrov, MD 972-50-8840757 morami12@gmail.com

Locations
Israel
Laniado Hospital Recruiting
Natania, Israel
Contact: Birgita Weintrov, MD            
Principal Investigator: Brigita Weintrov, MD            
Sponsors and Collaborators
Laniado Hospital
Investigators
Study Director: Brigita Wintrov, MD Laniado Medical Center
  More Information

No publications provided

Responsible Party: Laniado Hospital
ClinicalTrials.gov Identifier: NCT01735695     History of Changes
Other Study ID Numbers: Laniado25112012, Laniado25122012-1
Study First Received: November 25, 2012
Last Updated: April 28, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Laniado Hospital:
Meconium
concentration
level

ClinicalTrials.gov processed this record on May 23, 2013