Screening, enrollment, randomization and follow-up procedures
malaria
MALARIA
Pregnant women attending antenatal clinics in three peripheral health centres of the Yako health district catchment areas were invited to participate. Data at screening were extracted from the mothers’ ANC books or by the mother interview when the information was not available in the ANC books. Age, gyneco-obstetrical history, SP uptake, literacy (ability or not to read and write), occupation (having or not an income-generating activity), number of pregnancies (1-primigravida, 2-secondigravida, or ≥ 3-multigravida), and the use of bed nets the night before ANC visit were collected. In addition to physical and obstetrical examinations, blood pressure, axillary temperature, and body weight (during the first ANC visit) were measured, completed by malaria diagnosis in peripheral blood samples by microscopy (positive if any density of asexual malaria parasite), haemoglobin level by spectrophotometry (HemoCue, Ängelholm, Sweden) and body mass index (BMI) [derived by body weight (in kilograms) divided by the square of the height (in metres)].After baseline characteristics were recorded, eligible pregnant women were randomized at 1:1 ratio to either use azithromycin (1 g daily for 2 days) during the second and third trimesters of pregnancy plus monthly sulfadoxine-pyrimethamine (1500/75 mg) (SPAZ) (intervention) or to continue using a monthly sulfadoxine-pyrimethamine (1500/75 mg) (SP) (control). Each treatment (SPAZ or SP) was randomly assigned to two different treatment codes, (letters A and B). A block randomization procedure was conducted and each block containing four treatment code were prepared by an offsite trial data management team at the CRUN. Allocation codes were kept in consecutively numbered sealed envelopes and revealed after completion of enrolment and immediately prior to treatment. Although, this was not a blinded study in the field and at patient level, other investigators were unaware of the trial group assignment except for the statistician. The intervention consisted of monthly courses of sulfadoxine-pyrimethamine (3 tablets [500/25 mg] given once, Micro Labs Ltd., India) starting early in the second trimester until delivery and azithromycin (2 tablets [500 mg] once daily for 2 days, Pfizer, USA) in the second and third trimesters of pregnancy. The control treatment consisted of monthly sulfadoxine-pyrimethamine (3 tablets [500/25 mg] given once, Micro Labs Ltd., India). Treatment administrations were supervised by a trained nurse or a trained field worker.