A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success
Bright I Nwaru, Saara Parkkali, Fatima Abacassamo, Graca Salomé, Baltazar Chilundo, Orvalho Augusto, Julie Cliff, Martinho Dgedge, Elena Regushevskaya, Minna Nikula, Elina Hemminki, Bright I Nwaru, Saara Parkkali, Fatima Abacassamo, Graca Salomé, Baltazar Chilundo, Orvalho Augusto, Julie Cliff, Martinho Dgedge, Elena Regushevskaya, Minna Nikula, Elina Hemminki
Abstract
The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 μg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well.
Trial registration: ClinicalTrials.gov NCT00488579.
Keywords: HIV; birth outcomes; clinical trials; developing countries; infections; iron; malaria; micronutrients; pregnancy; pregnancy outcomes.
Conflict of interest statement
The authors declare that they have no conflicts of interest.
© 2012 Blackwell Publishing Ltd.
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Source: PubMed