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Performance Evaluation Study for a New Meconium Detection Test

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Laniado Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735695
First Posted: November 28, 2012
Last Update Posted: April 30, 2013
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.
Information provided by (Responsible Party):
Laniado Hospital
  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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laniado Hospital
ClinicalTrials.gov Identifier: NCT01735695     History of Changes
Other Study ID Numbers: Laniado25112012
Laniado25122012-1 ( Other Identifier: Laniado Hospital )
First Submitted: November 25, 2012
First Posted: November 28, 2012
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Laniado Hospital:
Meconium
concentration
level