Performance Evaluation Study for a New Meconium Detection Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01735695
Recruitment Status : Unknown
Verified April 2013 by Laniado Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2012
Last Update Posted : April 30, 2013
Information provided by (Responsible Party):
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.

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance Evaluation Study for a New Meconium Detection Test
Study Start Date : December 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : December 2013

Primary Outcome Measures :
  1. Meconium concentration in amniotic fluid [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01735695

Contact: Brigita Weitrov, MD 972-50-8840757

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

Responsible Party: Laniado Hospital Identifier: NCT01735695     History of Changes
Other Study ID Numbers: Laniado25112012
Laniado25122012-1 ( Other Identifier: Laniado Hospital )
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Laniado Hospital: