Pregnancy Loss Database and Tissue Bank

Principal Investigator: Bob Silver
Keywords: recurrent pregnancy loss , miscarriage Department: Obstetrics And Gynecology (Dept)
IRB Number: 00029077 Co Investigator: Bob Silver
Specialty: Maternal-Fetal Medicine
Sub Specialties: Recurrent Miscarriage
Recruitment Status: Enrolling by invitation

Contact Information

Kerri Pitcher

Brief Summary

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.

Inclusion Criteria

This study will involve two different groups of participants:

1. Female participants who were previously enrolled in OB/GYN recurrent pregnancy loss studies.

2. Participants (male and female) who are new to the Obstetrics and Gynecology Research Network (OGRN).

Recurrent pregnancy loss patients are defined as women greater than 18 years of age or less than 45 years of age who have had two or more consecutive pregnancy losses, regardless of whether a possible etiology had been discovered by thorough evaluation. Men who have spouses with recurrent pregnancy loss will also be recruited into the study. We will recruit men in the same age range 18-45.

Exclusion Criteria

No patients will be excluded on the basis of medical disease; although, seriously ill patients, in who gathering accurate information may be difficult will not be used in this study. In addition, mentally retarded patients and incarcerated individuals will not be included in this study.