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卢旺达部分地区妊娠间歇性疟疾筛查和治疗对母婴结局的影响:一项整群随机对照试验。

Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy on Maternal and Birth Outcomes in Selected Districts in Rwanda: A Cluster Randomized Controlled Trial.

机构信息

Malaria and Other Parasitic Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.

Maternal and Child Survival Program-Jhpiego, Washington, District of Columbia, USA.

出版信息

Clin Infect Dis. 2023 Jul 5;77(1):127-134. doi: 10.1093/cid/ciad128.

DOI:10.1093/cid/ciad128
PMID:36896967
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10330390/
Abstract

BACKGROUND

Malaria during pregnancy can cause serious consequences including maternal anemia and low birthweight (LBW). Routine antenatal care (ANC) in Rwanda includes malaria symptom screening at each ANC visit. This cluster randomized controlled trial investigated whether adding intermittent screening with a malaria rapid diagnostic test at each routine ANC visit and treatment of positives during pregnancy (ISTp) is more effective than routine ANC for reducing malaria prevalence at delivery.

METHODS

Between September 2016 and June 2018, pregnant women initiating ANC at 14 health centers in Rwanda were enrolled into ISTp or control arms. All women received an insecticide-treated bed net at enrollment. Hemoglobin concentration, placental and peripheral parasitemia, newborn outcome, birthweight, and prematurity were assessed at delivery.

RESULTS

Nine hundred seventy-five women were enrolled in ISTp and 811 in the control group. Routine ANC plus ISTp did not significantly reduce polymerase chain reaction-confirmed placental malaria compared to control (adjusted relative risk [aRR], 0.94 [95% confidence interval {CI}, .59-1.50]; P = .799). ISTp had no impact on anemia (aRR, 1.08 [95% CI, .57-2.04]; P = .821). The mean birthweight of singleton newborns was not significantly different between arms (3054 g vs 3096 g, P = .395); however, women in the ISTp arm had a higher proportion of LBW (aRR, 1.59 [95% CI, 1.02-2.49]; P = .042).

CONCLUSIONS

This is the only study to compare ISTp to symptomatic screening at ANC in a setting where intermittent preventive treatment is not routinely provided. ISTp did not reduce the prevalence of malaria or anemia at delivery and was associated with an increased risk of LBW.

CLINICAL TRIALS REGISTRATION

NCT03508349.

摘要

背景

孕妇疟疾可导致严重后果,包括母体贫血和低出生体重(LBW)。卢旺达常规产前保健(ANC)包括每次 ANC 就诊时进行疟疾症状筛查。这项整群随机对照试验研究了在每次常规 ANC 就诊时增加间歇性疟疾快速诊断检测(ISTp)筛查和治疗孕妇疟疾(ISTp)是否比常规 ANC 更能降低分娩时疟疾的患病率。

方法

2016 年 9 月至 2018 年 6 月,在卢旺达的 14 个卫生中心开始 ANC 的孕妇被纳入 ISTp 或对照组。所有妇女在入组时都收到了驱虫蚊帐。在分娩时评估血红蛋白浓度、胎盘和外周寄生虫血症、新生儿结局、出生体重和早产。

结果

975 名妇女被纳入 ISTp 组,811 名妇女被纳入对照组。与对照组相比,常规 ANC 加 ISTp 并不能显著降低聚合酶链反应确认的胎盘疟疾(调整后的相对风险 [aRR],0.94 [95%置信区间 {CI},.59-1.50];P =.799)。ISTp 对贫血没有影响(aRR,1.08 [95% CI,.57-2.04];P =.821)。单胎新生儿的平均出生体重在两组之间无显著差异(3054 克与 3096 克,P =.395);然而,ISTp 组的低出生体重(LBW)比例较高(aRR,1.59 [95% CI,1.02-2.49];P =.042)。

结论

这是唯一一项将 ISTp 与 ANC 中的症状筛查进行比较的研究,该研究在间歇性预防治疗未常规提供的环境中进行。ISTp 并不能降低分娩时疟疾或贫血的患病率,并且与 LBW 的风险增加有关。

临床试验注册

NCT03508349。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9b5/10517094/e82170d023e9/ciad128_ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9b5/10517094/e82170d023e9/ciad128_ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9b5/10517094/e82170d023e9/ciad128_ga1.jpg

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