Intravenous iron for non-anaemic iron deficiency in pregnancy: a multicentre, two-arm, randomised controlled trial.

This study evaluated whether the addition of intravenous iron to routine oral prophylaxis had an effect on maternal haemoglobin concentration before delivery in non-anaemic iron deficient pregnant women.

本研究评估了在非贫血性铁缺乏孕妇中，将静脉注射铁剂添加到常规口服预防治疗中，是否会影响分娩前的母体血红蛋白浓度。

Methods

In this multicentre, two-arm, randomised trial done at three teaching hospitals in Lahore, Pakistan, pregnant women aged 18 years or older with a singleton pregnancy were screened at the first antenatal care booking visit for non-anaemic iron deficiency (haemoglobin 11-13 g/dL at booking with ferritin <30 μg/L).

在这项在巴基斯坦拉合尔的三家教学医院进行的多中心、两臂、随机试验中，对年龄在18岁或以上的单胎妊娠孕妇在首次产前护理预约时进行了筛查，以确定非贫血性铁缺乏（首次预约时血红蛋白为11-13 g/dL，铁蛋白<30 μg/L）。

Women with high haemoglobin concentrations were excluded.

血红蛋白浓度高的女性被排除在外。

Participants were randomly assigned (1:1) to an intervention during the second trimester using serially numbered, opaque, identical boxes, prepared by a third party using computer-generated random numbers with variable block sizes.

参与者被随机分配（1:1），在第二孕期使用按顺序编号、不透明、相同的盒子进行干预，这些盒子由第三方使用计算机生成的随机数字和可变的块大小准备。

Participants were assigned to either receive 1000 mg of intravenous iron in addition to routine oral iron prophylaxis, or to receive prophylactic 30 mg oral iron daily as the standard of routine care throughout pregnancy.

参与者被分配要么接受1000毫克静脉注射铁剂加上常规口服铁剂预防，要么接受每天30毫克口服铁剂作为整个孕期的常规护理标准。

Outcome assessors were masked to group allocation.

结果评估者对分组分配情况不知情。

Participants were followed up to delivery.

参与者被跟踪至分娩。

The primary outcome was the mean change in maternal haemoglobin concentration from baseline to 36 weeks' gestation.

主要结果是孕母血红蛋白浓度从基线到妊娠36周的平均变化。

We performed the primary analysis applying the intention-to-treatprinciple in all randomly assigned participants who had data for the primary outcome available (full analysis set).

我们对所有有主要结果数据的随机分配参与者进行了主要分析，应用了意向治疗原则（完整分析集）。

We assessed participants for serious or life-threatening adverse events such as death, cardiac arrest, myocardial infarction, anaphylactic shock, and reactions leading to intensive care admission and discontinuation of treatment.

我们评估了参与者出现的严重或危及生命的不良事件，如死亡、心脏骤停、心肌梗死、过敏性休克以及导致重症监护病房入院和治疗中断的反应。

The trial is registered at ClinicalTrials.gov number, NCT04228627, and is completed.

该试验已在ClinicalTrials.gov注册，编号为NCT04228627，并已完成。

Results

Between Jan 14, 2020, to Aug 29, 2023, 1206 women were screened for eligibility, 606 were ineligible for participation due to reasons including age, gestational age, and haemoglobin concentration, and 600 were enrolled in the study. 295 women were assigned to the intravenous iron group and 305 were assigned to the oral iron prophylaxis group, and all were followed up until delivery. 228 women delivered in the intravenous iron group (14 preterm), and 234 women delivered in the oral iron prophylaxis group (21 preterm; three without primary outcome data).

在2020年1月14日至2023年8月29日期间，共有1206名女性进行了资格筛查，其中606名因年龄、妊娠年龄和血红蛋白浓度等原因不符合参与条件，600名被纳入研究。295名女性被分配到静脉铁剂组，305名被分配到口服铁剂预防组，所有人均被跟踪随访至分娩。静脉铁剂组有228名女性分娩（其中14名为早产），口服铁剂预防组有234名女性分娩（其中21名为早产；有三名未获得主要结果数据）。

Maternal haemoglobin concentration before delivery was 11·6 g/dL (SD 0·5) in the intravenous iron group and 10·8 g/dL (0·7) in the prophylactic oral iron group (mean difference, 0·74 g/dL [95% CI 0·64-0·85]; p<0·0001).

分娩前，静脉铁剂组的孕妇血红蛋白浓度为11.6 g/dL（标准差0.5），预防性口服铁剂组为10.8 g/dL（标准差0.7）（平均差异，0.74 g/dL [95% 置信区间0.64-0.85]；p<0.0001）。

None of the participants experienced serious or life-threatening adverse events.

参与研究的患者中没有人经历严重的或危及生命的不良事件。

interpretation

Among non-anaemic iron deficient pregnant women, intravenous iron therapy significantly improved maternal haemoglobin before delivery, compared with oral iron prophylaxis.

在非贫血性铁缺乏的孕妇中，与口服铁预防相比，静脉铁治疗显著改善了分娩前的母体血红蛋白水平。

Ferritin screening should be considered in early pregnancy, as intravenous iron therapy is effective in those tested positive for non-anaemic deficiency.

应在早期妊娠时考虑进行铁蛋白筛查，因为对于检测出非贫血性铁缺乏的个体，静脉补铁治疗是有效的。

funding

None.

无。