Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT)

Study design and Patient recruitment The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Informed consent will be obtained after the purpose, procedure, benefits, discomfort, risks and precautions associated with the study have been dully explained to them. Due diligence will be taken in adequately responding to any question or concern raised about the study. It will fully be explained to them that their participation is entirely voluntary. Also, if they are unwilling at any point to participate, they will be completely at liberty to discontinue their participation in the study which will not in any away affect their further and adequate management in the hospital. It will be explained that their participation in the study will not have any negative impact on them and their unborn babies and it has no financial benefits but the outcomes of the study may contribute to improved antenatal care. However, if there is additional financial cost (though not immediately foreseen) to any patient outside the cost of routine ANC visit, the investigator shall arrange for modest compensation. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.