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)

Abstract

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).

Effect of Educational Handouts With Standard Therapy Versus Standard Therapy Alone on Compliance With Oral Iron Supplementation in Antenatal Women With Iron Deficiency Anemia: A Randomized Controlled Trial

“…The majority of the prenatal women in the current study were between the ages of 25 and 30 years. However, Khorshid et al [ 13 ], Byamugisha et al [ 14 ], Ahamed et al [ 15 ], Kaundal et al [ 16 ], Sunuwar et al [ 12 ], Abujilban et al [ 17 ], Srivastava et al [ 18 ], Nahrisah et al [ 19 ], Bumrungpert et al [ 20 ], Sontakke et al [ 21 ], Mithra et al [ 22 ], Dutta et al [ 23 ], Kassa et al [ 24 ], and Boti et al [ 25 ] reported mean ages ranging from 22-30 years of age. Similar to a study done by Sontakke et al [ 21 ], pregnant women in the present study were equally divided according to their parity status as nulliparous and multiparous in intervention and non-interventional groups.…”

“…Similar to a study done by Sontakke et al [ 21 ], pregnant women in the present study were equally divided according to their parity status as nulliparous and multiparous in intervention and non-interventional groups. There were fewer multiparous women than nulliparous in previous studies undertaken by Wiradnyani et al [ 26 ], Byamugisha et al [ 14 ], Nahrisah et al [ 19 ], and Kassa et al [ 24 ]. Comparatively, only a few other studies by Boti et al [ 25 ] and Khorshid et al [ 13 ] included more nulliparous women.…”

“…Doubts of the patients were cleared, and if they were illiterate, their relatives accompanying them were explained, and they were told to read the handouts frequently, so as to enhance the importance of iron supplementation in antenatal women. Khorshid et al [ 13 ], Byamugisha et al [ 14 ], Ahamed et al [ 15 ], Kaundal et al [ 16 ], Sunuwar et al [ 12 ], Abujilban et al [ 17 ], and Srivastava et al [ 18 ] reported the gestational age between 14 and 24 weeks (second trimester of pregnancy), supporting the findings of the present study, except a study conducted by Nahrisah et al [ 19 ] who included antenatal women from all gestational ages. The present study included antenatal women with hemoglobin between 9 and 10.9 gm/dl, having AA pattern on hemoglobin electrophoresis, who were capable of reading in Hindi, Marathi, or English or at least have a relative accompanying them who can read.…”

“…Mithra et al [ 22 ], Khorshid et al [ 13 ], Dutta et al [ 23 ], Wiradnyani et al [ 26 ], Byamugisha et al [ 14 ], Boti et al [ 25 ], Ahamed et al [ 15 ], Abujilban et al [ 17 ], Kassa et al [ 24 ], Srivastava et al [ 18 ], Bumrungpert et al [ 20 ], and Sontakke et al [ 21 ] applied either compliance or adherence or pill count to assess the oral intake of iron tablets. Although these studies employed compliance, adherence, and pill count to gauge the results, there are no set criteria to distinguish between great and poor compliance with iron supplementation during pregnancy.…”

Adherence to iron supplementation among anemic pregnant women during 1964-2022: A bibliometric analysis

“…For instance, Iran's research analyzed the impact of Short Message Service messaging on compliance (Khorshid et al, 2014). Indonesia's deployment of mobile management software to monitor the compliance of Fe supplementation (Rukmaini, 2018), a low-to middle-income country's usage of packing in blisters for Iron and Folate in an IFAd trial (Byamugisha et al, 2022), and the use of integrated pictorial handbook counseling (Nahrisah et al, 2020). However, some interventions did not improve anemia after the end of the experiment (Byamugisha et al, 2022;Rukmaini, 2018).…”