Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00373139
First received: September 6, 2006
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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 Phase
Pregnancy
Phase 0

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Detection of Pregnancy [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.


Enrollment: 633
Study Start Date: July 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373139

Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Investigators
Principal Investigator: Christian Fromm, MD Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00373139     History of Changes
Other Study ID Numbers: 03/08/VA11
Study First Received: September 6, 2006
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:
Pregnancy,
Screening,
Whole Blood

ClinicalTrials.gov processed this record on October 23, 2014