Pregnancy Clinical Trial
Official title:
Accuracy of Whole-Blood Testing for Rapid Detection of Pregnancy
Verified date | December 2013 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 633 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Antonios Likourezos |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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