To ensure the safety of participants and the validity and integrity of the data a Data and Safety Monitoring Board (DSMB) will be created to follow the study. The DSMB will consist of 5 experts members representing the following institutions and not involved with this trial: Bill and Melinda Gates Foundation, Ministry of Health of Brazilian Government, IMIP, Dom Malan Hospital and an statistician. The DSMB will periodically review the accumulated study data for pregnant women and fetus safety, study conduct, progress and efficacy. DSMB also can make recommendations to continuation, modification or termination of this trial.