Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy
Completed
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT00373139
- Run by
- Antonios Likourezos
- People needed
- 633
- Starts
- 2006-07-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2013-12-30
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.
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.
Where it is running
- Maimonides Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.