Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy
This study has been completed.
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center
First received: September 6, 2006
Last updated: December 27, 2013
Last verified: December 2013
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Healthy ED adult women of child bearing age.
- Healthy adult women of child bearing age.
- Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
- 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.
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
|Maimonides Medical Center
|Brooklyn, New York, United States, 11219 |
||Christian Fromm, MD
||Maimonides Medical Center
No publications provided
||Antonios Likourezos, Research Manager, Maimonides Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 6, 2006
||December 27, 2013
||United States: Institutional Review Board
Keywords provided by Maimonides Medical Center:
ClinicalTrials.gov processed this record on August 27, 2015