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Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy

NCT00373139 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 633

Last updated 2013-12-30

No results posted yet for this study

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.

Conditions

  • Pregnancy

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Christian Fromm, MD · Maimonides Medical Center

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00373139 on ClinicalTrials.gov