低剂量阿司匹林在撒哈拉以南非洲国家预防妊娠高血压疾病的有效性：随机临床试验

IF 2.1 4区医学 Q2 OBSTETRICS & GYNECOLOGY

European journal of obstetrics, gynecology, and reproductive biology Pub Date : 2024-10-30 DOI:10.1016/j.ejogrb.2024.10.052

P.Z. Mkhize , V. Dorsamy , O.P. Khaliq , C. Bagwandeen , J. Moodley

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引用次数: 0

摘要

目的评估每日服用低剂量阿司匹林（LDA）能否预防南非孕妇的妊娠高血压疾病（HDP），包括子痫前期，并评估其对相关孕产妇和胎儿结局（如早产和新生儿并发症）的影响。研究设计这项单中心、开放标签、平行组随机对照试验（RCT）于2021年5月至2024年3月在南非夸祖鲁-纳塔尔省德班市的一家地区医院进行。共有 423 名年龄在 18 岁或以上、妊娠 12-20 周的单胎孕妇被随机分配到每天服用 162 毫克 LDA 或接受标准护理。主要结果是HDP的发生率，次要结果包括早发子痫前期（EOPE）、早产、低出生体重（LBW）和新生儿死亡。数据分析采用相对风险（RR）和95%置信区间（CI）。LDA组的HDP发生率明显降低（6.2% vs. 25.2%；RR = 0.25，95 % CI [0.14-0.44]，p <0.001），相当于HDP风险降低了75%，绝对风险降低率（ARR）为19%，治疗需要量（NNT）为5.3。EOPE降低了（2.4% vs. 14.0%；RR = 0.17，95 % CI [0.07-0.41]，p <0.001），早产也降低了（6.7% vs. 26.2%；RR = 0.26，95 % CI [0.15-0.45]，p <0.001）。在低体重儿和新生儿死亡方面没有明显差异。敏感性分析证实了在16周前开始LDA的重要性，显示早期开始LDA可持续降低HDP发生率。这些研究结果支持在低资源环境中使用 LDA 预防妊娠期高血压疾病，并强调了早期干预对改善孕产妇和胎儿预后的价值。

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The effectiveness of low-dose aspirin for the prevention of hypertensive disorders of pregnancy in a sub-Saharan Africa Country: A randomized clinical trial

Objective

To evaluate whether a daily dose of low-dose aspirin (LDA) can prevent hypertensive disorders of pregnancy (HDP), including preeclampsia, among pregnant women in a South African cohort, and to assess its impact on related maternal and fetal outcomes, such as preterm birth and neonatal complications.

Study design

This single-center, open-label, parallel-group randomized controlled trial (RCT) was conducted at a regional hospital in Durban, KwaZulu-Natal, South Africa, from May 2021 to March 2024. A total of 423 pregnant women, aged 18 years or older with singleton pregnancies between 12 and 20 weeks of gestation, were randomized to receive either 162 mg of LDA daily or standard care. The primary outcome was the incidence of HDP, while secondary outcomes included early-onset preeclampsia (EOPE), preterm birth, low birth weight (LBW), and neonatal death. Data analysis used relative risk (RR) and 95 % confidence intervals (CIs).

Results

Of the 423 women, 209 were in the LDA group and 214 in the control group. The incidence of HDP was significantly lower in the LDA group (6.2 % vs. 25.2 %; RR = 0.25, 95 % CI [0.14–0.44], p < 0.001), corresponding to a 75 % reduction in HDP risk, with an absolute risk reduction (ARR) of 19 % and a number needed to treat (NNT) of 5.3. EOPE was reduced (2.4 % vs. 14.0 %; RR = 0.17, 95 % CI [0.07–0.41], p < 0.001), as was preterm birth (6.7 % vs. 26.2 %; RR = 0.26, 95 % CI [0.15–0.45], p < 0.001). There were no significant differences for LBW or neonatal death. Sensitivity analysis confirmed the importance of initiating LDA before 16 weeks, showing continued reductions in HDP incidence with early initiation.

Conclusion

LDA significantly reduces the risk of HDP, EOPE, and preterm birth, particularly when initiated before 16 weeks of gestation. These findings support the use of LDA for preventing hypertensive disorders of pregnancy in low-resource settings and underscore the value of early intervention for improved maternal and fetal outcomes.

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来源期刊

European journal of obstetrics, gynecology, and reproductive biology 医学-妇产科学

CiteScore

4.60

自引率

3.80%

发文量

898

审稿时长

8.3 weeks

期刊介绍： The European Journal of Obstetrics & Gynecology and Reproductive Biology is the leading general clinical journal covering the continent. It publishes peer reviewed original research articles, as well as a wide range of news, book reviews, biographical, historical and educational articles and a lively correspondence section. Fields covered include obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine and reproductive ethics. The European Journal of Obstetrics & Gynecology and Reproductive Biology provides a forum for scientific and clinical professional communication in obstetrics and gynecology throughout Europe and the world.