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).
Study Goal
The researchers aimed to determine whether blister-packaged Iron-Folic acid (IFA) pills improved adherence and hemoglobin levels compared to loose-packaged pills among pregnant women in Uganda.
Results Summary
The study found no significant difference in IFA adherence between blister and loose packaging groups, but blister packaging led to a higher increase in hemoglobin levels over 8 weeks. Hemoglobin levels were slightly higher in the blister group at 4 weeks, but similar at 8 weeks, with a greater overall change in the blister group.
Population
Pregnant women (≤28 weeks gestation) at two National Referral Hospitals in Kampala, Uganda.
Effective Dosage
30 IFA pills (one pill per day).
Duration
8 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
blister packaged Iron-Folic acid (IFA) pills | increase | hemoglobin level | pregnant women at two National Referral Hospitals in Kampala, Uganda | 11.9 + 1.1 g/dl vs 11.8 + 1.3 g/dl | had a higher mean hemoglobin level | #1 |
blister packaged Iron-Folic acid (IFA) pills | increase | hemoglobin level | pregnant women at two National Referral Hospitals in Kampala, Uganda | 0.6 ± 1.0 vs 0.2 ± 1.1; difference: 0.4 g/dL (95% CI: 0.24-0.51 g/dL) | had a higher change in hemoglobin level | #2 |
blister packaged Iron-Folic acid (IFA) pills | no change | IFA adherence | pregnant women at two National Referral Hospitals in Kampala, Uganda | - | showed no effect on IFA adherence | #3 |
blister packaged Iron-Folic acid (IFA) pills | no change | adherence to IFA intake | pregnant women at two National Referral Hospitals in Kampala, Uganda | 40.6% vs 39.0% at 4th week | was similar in adherence | #4 |
blister packaged Iron-Folic acid (IFA) pills | no change | adherence to IFA intake | pregnant women at two National Referral Hospitals in Kampala, Uganda | 51.9% vs 46.8% at 8th week | was similar in adherence | #5 |
blister packaged Iron-Folic acid (IFA) pills | no change | hemoglobin level | pregnant women at two National Referral Hospitals in Kampala, Uganda | 12.1 + 1.2 vs 12.0 + 1.3 at week 8 | had similar mean hemoglobin level | #6 |
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).