Comparison of routine prenatal iron prophylaxis and screening and treatment for anaemia: pregnancy results and preliminary birth results from a pragmatic randomised controlled trial (PROFEG) in Maputo, Mozambique

Saara Parkkali, Fatima Abacassamo, Bright Ibeabughichi Nwaru, Graca Salomé, Orvalho Augusto, Elena Regushevskaya, Martinho Dgedge, Cesar Sousa, Julie Cliff, Baltazar Chilundo, Elina Hemminki, Saara Parkkali, Fatima Abacassamo, Bright Ibeabughichi Nwaru, Graca Salomé, Orvalho Augusto, Elena Regushevskaya, Martinho Dgedge, Cesar Sousa, Julie Cliff, Baltazar Chilundo, Elina Hemminki

Abstract

Objective: To present the pregnancy results and interim birth results of a pragmatic randomised controlled trial comparing routine iron prophylaxis with screening and treatment for anaemia during pregnancy in a setting of endemic malaria and HIV.

Design: A pragmatic randomised controlled trial.

Setting: Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV.

Participants: Pregnant women (≥18-year-olds; non-high-risk pregnancy, n=4326) attending prenatal care consultation at the two health centres were recruited to the trial.

Interventions: The women were randomly allocated to either Routine iron (n=2184; 60 mg ferrous sulfate plus 400 μg of folic acid daily throughout pregnancy) or Selective iron (n=2142; screening and treatment for anaemia and daily intake of 1 mg of folic acid).

Outcome measures: The primary outcomes were preterm delivery (delivery <37 weeks of gestation) and low birth weight (<2500 g). The secondary outcomes were symptoms suggestive of malaria and self-reported malaria during pregnancy; birth length; caesarean section; maternal and child health status after delivery.

Results: The number of follow-up visits was similar in the two groups. Between the first and fifth visits, the two groups were similar regarding the occurrence of fever, headache, cold/chills, nausea/vomiting and body aches. There was a suggestion of increased incidence of self-reported malaria during pregnancy (OR 1.37, 95% CI 0.98 to1.92) in the Routine iron group. Birth data were available for 1109 (51%) in the Routine iron group and for 1149 (54%) in the Selective iron group. The birth outcomes were relatively similar in the two groups. However, there was a suggestion (statistically non-significant) of poorer outcomes in the Routine iron group with regard to long hospital stay after birth (relative risk (RR) 1.43, 95% CI 0.97 to 1.26; risk difference (RD) 0.02, 95% CI -0.00 to 0.03) and unavailability of delivery data (RR 1.06, 95% CI 1.00 to 1.13; RD 0.03, 95% CI -0.01 to 0.07).

Conclusions: These interim results suggest that routine iron prophylaxis during pregnancy did not confer advantage over screening and treatment for anaemia regarding maternal and child health. Complete data on birth outcomes are being collected for firmer conclusions.

Trial registration: The trial is registered at ClinicalTrials.gov, number NCT00488579 (June 2007). The first women were randomised to the trial proper April 2007-March 2008. The pilot was November 2006-March 2008. The 3-month lag was due to technical difficulties in completing trial registration.

Figures

Figure 1
Figure 1
PROFEG Trial flow diagram. 1ARO, high-risk pregnancy; 2GA, gestational age in weeks; 3After recruitment, % were calculated from recruited, n=4326.

References

    1. Peña-Rosas JP, Viteri FE. Effects and safety of preventive oral iron or iron+folic acid supplementation for women during pregnancy. Cochrane Database Syst Rev 2009;(4):CD004736.
    1. Villar J, Merialdi M, Gulmezoglu AM, et al. Nutritional interventions during pregnancy for the prevention or treatment of maternal mortality and preterm delivery: an overview of randomized controlled trials. J Nutr 2003;133:1606–25
    1. Lao TT, Tam KF, Chan LY. Third trimester iron status and pregnancy outcome in non-anaemic women: pregnancy unfavourably affected by maternal iron excess. Hum Reprod 2000;15:1843–8
    1. Yip R. Significance of an abnormally low or high hemoglobin concentration during pregnancy: special consideration of iron nutrition. Am J Clin Nutr 2000;72:272S–9S
    1. Oppenheimer SJ. Iron and its relation to immunity and infectious disease. J Nutr 2001;131:616S–35S
    1. Prentice AM. Iron metabolism, malaria, and other infections: what is all the fuss about? J Nutr 2008;138:2537–41
    1. Gera T, Sachdev HP. Effect of iron supplementation on incidence of infectious illness in children: systematic review. BMJ 2002;325:1142.
    1. Lawn JE, Cousens S, Zupan J, Lancet Neonatal Survival Steering Team 4 million neonatal deaths: when? Where? Why? Lancet 2005;365:891–900
    1. Idemyor V. Human immunodeficiency virus (HIV) and malaria interaction in sub-Saharan Africa: the collision of two Titans. HIV Clin Trials 2007;8:246–53
    1. Juncker T, Ameer S, Mmaum A, et al. A trial of iron and folate supplementation during pregnancy in Bangladesh. Abstract presented at the American Public Health Association, 2001, Atlanta, Georgia, USA
    1. Fleming AF, Ghatoura GB, Harrison KA, et al. The prevention of anaemia in pregnancy in primigravidae in the guinea savanna of Nigeria. Ann Trop Med Parasitol 1986;80:211–33
    1. Menendez C, Todd J, Alonso PL, et al. The effects of iron supplementation during pregnancy, given by traditional birth attendants, on the prevalence of anaemia and malaria. Trans R Soc Trop Med Hyg 1994;88:590–3
    1. Preziosi P, Prual A, Galan P, et al. Effect of iron supplementation on the iron status of pregnant women: consequences for newborns. Am J Clin Nutr 1997;66:1178–82
    1. Ndyomugyenyi R, Magnussen P. Chloroquine prophylaxis, iron/folic-acid supplementation or case management of malaria attacks in primigravidae in western Uganda: effects on congenital malaria and infant haemoglobin concentrations. Ann Trop Med Parasitol 2000;94:759–70
    1. Christian P, Khatry SK, Katz J, et al. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: a double blind randomized community trial. BMJ 2003;326:571.
    1. Christian P, West KP, Khatry SK, et al. Effects of maternal micronutrient supplementation on fetal loss and infant mortality: a cluster-randomized trial in Nepal. Am J Clin Nutr 2003;78:1194–202
    1. Christian P, Darmstadt GL, Wu L, et al. . The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomized, control, community trial. Arch Dis Child 2008;93:660–4
    1. Christian P, Khatry SK, LeClerq SC, et al. Effects of prenatal micronutrient supplementation on complications of labor and delivery and puerperal morbidity in rural Nepal. Int J Gynaecol Obstet 2009;106:3–7
    1. Christian P, Stewart CP, LeClerq SC, et al. Antenatal and postnatal iron supplementation and childhood mortality in rural Neap: a prospective follow-up in a randomized, controlled community trial. Am J Epidemiol 2009;170:1127–36
    1. Christian P, Murray-Kolb LE, Khatry SK, et al. Prenatal micronutrient supplementation and intellectual and motor function in early school-aged children in Nepal . JAMA 2010;304:2716–23
    1. Zeng L, Dibley MJ, Cheng Y, et al. Impact of micronutrient supplementation during pregnancy on birth weight, duration of gestation, and perinatal mortality in rural western China: double blind cluster randomized controlled trial. BMJ 2008;337:a2001.
    1. Nwaru BI, Parkkali S, Abacassamo F, et al. A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, desgin, and success. Matern Child Nutr. In press
    1. Dgedge M. Implementation of an insecticide Bednet programme for malaria prevention through the primary health care system in Mozambique [Doctoral thesis]. London: London School of Hygiene and Tropical Medicine, 2000
    1. Müngen E. Iron supplementation in pregnancy. J Perinat Med 2003;31:420–6
    1. Brabin BJ, Hakimi M, Pelletier D. An analysis of anemia and pregnancy-related maternal mortality. J Nutr 2001;131(Suppl):604S–15S
    1. Stoltzfus RJ, Mullanny L, Black RE. Iron deficiency anaemia. In: Ezzati M, Lopez AD, Rodgers A, et al. ,eds. Comparative auantification of health risks: global and regional burden of disease attributable to selected major risk factors. Vol 1 Geneva, Switzerland: World Health Organization, 2004:163–209

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다