ADVERSE OUTCOMES OF VACUUM ASSISTED DELIVERY DEVICES The Food and Drug Administration intends to award a contract to the Valley Perinatal Medical Group, Tarzana, California for the project entitled "Adverse Outcomes of Vacuum Assisted Delivery Devices". This contract shall provide for the retrospective case series of perinatal deaths and long-term serious adverse outcomes of VADD which shall include: a) to define the relationship of indications of interventions to the adverse outcomes, b) explore circumstances surrounding the device use, and c) explore the possible relationship between experience of operator and the adverse outcomes. In addition, the contract shall provide for the retrospective case-control study which shall include: a) to explore how fetal monitoring patterns and evaluation of the course of labor influence the decision to use vacuum extraction, and b) to determine the relationship of risk factors identified in the case series to major endpoints including failure of the vacuum application (as indicated by use of forceps and/r cesarean section) and adverse outcomes (subgaleal hemorrhage, intracranical hemorrhage, cephalhematoma, should dystocia, lacerations etc.) E-MAIL: Susan Pearlman, Contract Specialist, spearlma@oc.fda.gov. Posted 05/21/99 (W-SN334274).

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