The effect of blister packaging Iron and Folate on adherence to medication and hemoglobin levels among pregnant women at National Referral Hospital antenatal clinics in a low to middle income country: a Randomised Controlled Trial (The IFAd Trial).

INTRODUCTION: Anemia in pregnancy is an important global public health problem. It is estimated that 38% of pregnant women worldwide are anemic. In Africa, literature from observational studies show 20% of maternal deaths are attributed to anemia. In Uganda, 50% of pregnant women have iron deficiency anaemia. The proportion of pregnant women receiving Iron-Folic acid (IFA) supplementation has improved. However, the number of IFA pills consumed is still low. We carried out a randomized controlled trial to determine the effect of dispensing blister and loose packaged IFA pills on adherence measured by count on next return visit and hemoglobin levels among pregnant women at two National Referral Hospitals in Kampala, Uganda. METHODS: This trial was conducted between April and October 2016. Nine hundred fifty pregnant women at ≤28 weeks were randomized to either the blister (intervention arm) or loose (control arm) packaged IFA. The participants completed the baseline measurements and received 30 pills of IFA at enrolment to swallow one pill per day. We assessed adherence by pill count and measured hemoglobin at four and 8 weeks. The results were presented using both intention-to-treat and per-protocol analysis. RESULTS: There were 474 participants in the control and 478 in the intervention arms. Adherence to IFA intake was similar in the two groups at 4th week (40.6 and 39.0%, p = 0.624) and 8th week (51.9 and 46.8%, p = 0.119). The mean hemoglobin level at 4 weeks was higher in the blister than in the loose packaging arms (11.9 + 1.1 g/dl and 11.8 + 1.3 g/dl, respectively; p = 0.02), however, similar at week 8 (12.1 + 1.2 and 12.0 + 1.3, respectively; p = 0.23). However, over the 8-week period blister packaging arm had a higher change in hemoglobin level compared to loose package (blister package 0.6 ± 1.0; loose packaging 0.2 ± 1.1; difference: 0.4 g/dL (95% CI: 0.24-0.51 g/dL); p = 0.001. There were no serious adverse events. CONCLUSIONS: Our results showed no effect of blister packaging on IFA adherence among pregnant women. However, our findings showed that blister packaged group had a higher hemoglobin increase compared to loose iron group. TRIAL REGISTRATION: No. PACTR201707002436264 (20 /07/ 2017).

Adherence to iron supplements among women receiving antenatal care at Mulago National Referral Hospital, Uganda-cross-sectional study.

BACKGROUND: Antenatal iron supplementation is a cost effective way of reducing iron deficiency anaemia among pregnant women in resource limited countries like Uganda. Poor adherence to iron supplements has limited its effectiveness in reducing maternal anaemia as evidenced by the high burden of iron deficiency anemia in Sub-saharan Africa. The aim of this study was to determine the level of and factors associated with adherence to iron supplementation among women attending antenatal clinic at Mulago National Referral Hospital, Kampala, Uganda. METHODS: Three hundred and seventy pregnant women were recruited in a cross sectional survey in Mulago National Referral Hospital antenatal clinic after informed consent between February and April 2014. Levels of adherence to iron supplements were assessed using visual analogue scale and factors associated collected using an interviewer administered questionnaire. RESULTS: About 12% (11.6%) of the mothers attending the antenatal clinic adhered to iron supplements over 30 day period. Mothers who had had four or more antenatal visits prior to the survey [odds ratio (OR) = 1.49, 95% confidence interval (CI) 1.12-1.97], had more than 2 week supply of iron supplements in the previous visit (OR 2.81, 95% CI 1.02-1.09), prior health education (OR 1.56, 95% CI 1.07-2.29) were more likely to adhere to iron supplements. Inadequate drug supplies and fear for side effects were the main reasons why participants missed the iron supplements. CONCLUSIONS: There was low adherence to iron supplements among mothers attending antenatal clinic at Mulago National Referral  Hospital. We recommend a national evaluation of adherence to iron supplements and look at ways of increasing adherence.