Performance Evaluation Study for a New Meconium Detection Test

April 28, 2013 updated by: Laniado Hospital
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Natania, Israel
        • Recruiting
        • Laniado Hospital
        • Contact:
          • Birgita Weintrov, MD
        • Principal Investigator:
          • Brigita Weintrov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Meconium concentration in amniotic fluid
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laniado Hospital

Investigators

  • Study Director: Brigita Wintrov, MD, Laniado Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

November 25, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 28, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Laniado25112012
  • Laniado25122012-1 (Other Identifier: Laniado Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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