Background The weekly intake of oral iron–folic acid in pregnancy is an optional recommendation by the World Health Organization and the International Federation of Gynaecology and Obstetrics (FIGO). Although evidence was limited to justify its benefit or harm in Ethiopia, weekly iron–folic acid could be optional in the regions of Ethiopia. This trial compared twice‐weekly versus daily regimens for the outcomes of haemoglobin level and gastric side effects. Methods An open‐label, noninferiority randomized controlled trial was employed in the maternity clinics of southern Ethiopia. Eligibility criteria were as follows: age (18–40 years), gestation (12–20 weeks) and haemoglobin level (11–13 g/dL). Participants were randomly assigned to a treatment and control arm using blocks of six, and a sealed envelope was used by a statistician, not a trial member. The control arm received a single capsule of the daily iron–folic acid regimen, and the intervention arm received a double capsule of the twice‐weekly regimen. The primary outcome was blood haemoglobin levels. The secondary outcome was gastrointestinal and related side effects. Results A total of 282 participants were enrolled in the intervention cohort. Participants who completed 12 weeks of follow‐up were 271. Participant characteristics were balanced at baseline. Analysis output suggests no clinical differences between the groups for the mean maternal blood haemoglobin level and the incidence of anaemia. The risk of high haemoglobin concentration was not different between the groups. The gastrointestinal side effect was 33% less likely in the twice‐weekly group than in the daily group. Conclusions The twice‐weekly regimen was clinically noninferior to the daily regimen. The new approach could be considered an alternative regimen in pregnancy. Trial Registration: Pan African Clinical Trials Registry (PACTR): PACTR202402484795209
Chillo et al. (Thu,) studied this question.