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Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy

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ClinicalTrials.gov Identifier: NCT00373139
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Study Description
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Brief Summary:
It is common practice in the emergency medicine department to rapidly assess pregnancy status through the use of either urine or serum in pregnancy tests. Using whole blood instead of urine would facilitate a much more rapid emergency department identification of pregnancy status. No study to date has utilized whole blood for rapid detection of pregnancy status. Set in the busy adult emergency room at Maimonides Medical Center, this study will recruit a sample of women of reproductive age (18-55), who fit the inclusion criteria of being healthy and in need of a pregnancy test for own purpose or diagnostic testing/treatment. Blood samples will be taken from the participants and used in the hCG kits and the remaining blood was sent to the chemistry laboratory to perform the reference gold standard. The reference gold standard for a positive test is an hCG level >25mlU/ml. The research investigators and lab will be blinded to each other's results. Kappa statistics will be done for the measurement agreement between urine pregnancy results and whole blood pregnancy results, and whole blood results with laboratory results.

Condition or disease
Pregnancy

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Study Design
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Study Type : Observational
Actual Enrollment : 633 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy
Study Start Date : July 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Detection of Pregnancy [ Time Frame: Two years ]
    Blood will be assessed in a pregnancy kit to assess the sensitivity and specificity of detecting whether or not the patient is pregnant. The laboratory results will be the gold standard.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy ED adult women of child bearing age.
Criteria

Inclusion Criteria:

  1. Healthy adult women of child bearing age.
  2. Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.

Exclusion Criteria:

  1. Minors
  2. Adults who are unable to independently give consent for study
  3. Known pregnancy (i.e. - patient appears obviously pregnant)
  4. Hemodynamically unstable.
  5. Moderately to severely ill-appearing or in moderate to severe pain.
  6. Technically not possible to obtain blood from the study subject.
Contacts and Locations
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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): NCT00373139


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Christian Fromm, MD Maimonides Medical Center
More Information
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Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00373139     History of Changes
Other Study ID Numbers: 03/08/VA11
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013
Keywords provided by Antonios Likourezos, Maimonides Medical Center:
Pregnancy,
Screening,
Whole Blood