Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy

NCT00373139 | Completed

• 1 other identifier: 03/08/VA11
• Study Type: observational
• Target: 633
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy,; Screening,; Whole Blood

Outcome Measures

Primary Outcomes (1)

• Detection of Pregnancy

  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.

  Two years

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy ED adult women of child bearing age.

You may qualify if:

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

You may not qualify if:

• Minors
• Adults who are unable to independently give consent for study
• Known pregnancy (i.e. - patient appears obviously pregnant)
• Hemodynamically unstable.
• Moderately to severely ill-appearing or in moderate to severe pain.
• Technically not possible to obtain blood from the study subject.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Study Officials

• Christian Fromm, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 7, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

US (1)