Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy
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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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Enrollment: | 633 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2008 |
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 |
Healthy ED adult women of child bearing age.
Inclusion Criteria:
- Healthy adult women of child bearing age.
- Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
Exclusion Criteria:
- 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.
Contacts and Locations| United States, New York | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Principal Investigator: | Christian Fromm, MD | Maimonides Medical Center |
More Information
No publications provided
| Responsible Party: | Christian Fromm, MD, 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: | February 10, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Maimonides Medical Center:
|
Pregnancy, Screening, Whole Blood |
ClinicalTrials.gov processed this record on May 23, 2013