Risk mitigation plan

This is a low risk study so we do not anticipate serious adverse events. However, we will take precautions to ensure the safety of participants. Data collectors will be trained on HemoCue testing, how to communicate hemoglobin levels and anemia status to women following each test, and how to properly dispose of all HemoCue testing materials. While there will not be an independent assessment team to evaluate overall impact, we have put together an independent data safety and monitoring board (DSMB) to assess the outcomes on an ongoing process in order to ensure that the intervention does not inadvertently harm any participants.. The independent DSMB will review any serious adverse events and make recommendations for informing the IRB or stopping the study altogether. The DSMB includes researchers from India and the United States who will meet quarterly to review and discuss initial results from the study and any potential risks for participants.