In order to better understand pregnancy loss, we plan to establish a database and tissue bank comprised of bio-specimens from a population of patients having experienced pregnancy loss.
The bank and data base will be used to assess biochemical markers of pregnancy loss and test numerous hypotheses with primarily cohort-control studies.
Development of the bank and the database will greatly facilitate the rapid completion of such studies as hypotheses are developed. In addition, the creation of a “bank” and clinical data greatly facilitates the coordination of similar studies that involve the same cohort of patients. It is much simpler and more efficient for patients and investigators to work with one set of data, samples and consents. This type of arrangement would not work for all types of studies, but seems appropriate when 1) similar data and samples are required from a unique cohort, 2) participation involves only blood sampling and data collection regarding medical issues (minimal risk). The samples will be stored indefinitely as stated in the consent form.
Specific statistical methods, data analysis and interpretation plans will be submitted under future IRB applications once a hypothesis is identified and researchers need to access the samples for a study.