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Performance Evaluation Study for a New Meconium Detection Test

NCT ID: NCT01735695

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Keywords

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Meconium concentration level

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laniado Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigita Wintrov, MD

Role: STUDY_DIRECTOR

Laniado Medical Center

Locations

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Laniado Hospital

Netanya, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Brigita Weitrov, MD

Role: CONTACT

Phone: 972-50-8840757

Email: [email protected]

Facility Contacts

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Birgita Weintrov, MD

Role: primary

Other Identifiers

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Laniado25122012-1

Identifier Type: OTHER

Identifier Source: secondary_id

Laniado25112012

Identifier Type: -

Identifier Source: org_study_id