Health Services and Policy Research, National Institute for Health and Welfare, Helsinki, Finland.
BMJ Open. 2013 Feb 8;3(2). doi: 10.1136/bmjopen-2012-001948. Print 2013.
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.
A pragmatic randomised controlled trial.
Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV.
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.
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).
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.
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).
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.
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.
介绍一项实用随机对照试验的妊娠结局和中期出生结局，该试验比较了在疟疾和 HIV 流行地区常规铁预防与孕期贫血筛查和治疗的效果。
实用随机对照试验。
莫桑比克马普托的两个卫生中心（1° de Maio 和 Machava），疟疾流行地区，HIV 感染率较高。
参加两个卫生中心产前检查的孕妇（≥18 岁；非高危妊娠，n=4326）被招募参加试验。
将妇女随机分配到常规铁组（n=2184；整个孕期每天口服 60mg 硫酸亚铁和 400μg 叶酸）或选择性铁组（n=2142；筛查和治疗贫血，每天口服 1mg 叶酸）。
早产（<37 周分娩）和低出生体重（<2500g）。次要结局：疟疾症状和孕期自我报告疟疾；出生体长；剖宫产；分娩后母婴健康状况。
两组的随访就诊次数相似。在第一次和第五次就诊期间，两组发热、头痛、发冷/寒战、恶心/呕吐和身体疼痛的发生率相似。常规铁组孕期自我报告疟疾的发生率有增加的趋势（OR 1.37，95%CI 0.98 至 1.92）。常规铁组有 1109 名（51%）和选择性铁组有 1149 名（54%）的分娩数据。两组的分娩结局相对相似。然而，常规铁组出生后住院时间较长（相对风险（RR）1.43，95%CI 0.97 至 1.26；风险差（RD）0.02，95%CI -0.00 至 0.03）和分娩数据不可用（RR 1.06，95%CI 1.00 至 1.13；RD 0.03，95%CI -0.01 至 0.07）的可能性略高（统计学上无显著性）。
这些中期结果表明，孕期常规铁预防在母婴健康方面并未优于贫血筛查和治疗。正在收集完整的出生结局数据以得出更确定的结论。
该试验在 ClinicalTrials.gov 注册，编号为 NCT00488579（2007 年 6 月）。第一批妇女于 2007 年 4 月至 2008 年 3 月被随机分配到试验中。试点于 2006 年 11 月至 2008 年 3 月进行。3 个月的延迟是由于完成试验注册的技术困难。
