Department of Obstetrics and Gynecology, VMMC & Safdarjung Hospital, New Delhi, 110029, India.
Indian Council of Medical Research (ICMR), New Delhi, 110029, India.
Trials. 2024 Oct 15;25(1):679. doi: 10.1186/s13063-024-08520-z.
Hypertensive disorders of pregnancy (HDP) pose significant risks to maternal and fetal health, with substantial mortality and morbidity rates globally, particularly in developing countries. Pre-eclampsia (PE) accounts for a notable portion of maternal morbidity and mortality, with varied prevalence across regions within countries like India. Despite advancements, disparities in healthcare access persist, influencing outcomes. PE not only affects maternal health during pregnancy but also predisposes women to long-term cardiovascular complications, emphasizing the need for early screening and preventive measures.
This prospective randomized double-blind clinical trial aims to compare the efficacy and safety of 75 mg versus 150 mg aspirin for preventing preterm pre-eclampsia in high-risk women. Screen-positive women aged 18-45 years with singleton pregnancies between 12 and 16 weeks of gestational age will be enrolled. They will be randomized in a 1:1 ratio to receive either 75 mg or 150 mg of aspirin nightly until 37 weeks of pregnancy or earlier if preterm pre-eclampsia develops. Feto-maternal outcomes, including preterm pre-eclampsia incidence and neonatal and maternal complications, will be assessed. The sample size calculation based on expected proportions of preterm pre-eclampsia in both groups indicates a total of 370 participants (185 per group) accounting for 20% attrition.
This prospective randomized double-blind clinical trial aims to compare the effectiveness and safety of two doses of aspirin (75 mg vs 150 mg) in preventing preterm pre-eclampsia in high-risk women. The potential implications of this study are significant, including the optimization of aspirin prophylaxis, the development of evidence-based guidelines, and comprehensive assessment of maternal and fetal outcomes. In conclusion, the results of this study have the potential to significantly impact clinical practice by enhancing maternal and perinatal health outcomes and contributing to evidence-based obstetric care.
Clinical Trials Registry-India CTRI/2023/12/060983. Trial was registered prospectively on 29 December 2023. Acknowledgement Number REF/2023/12/076358. https://acrobat.adobe.com/id/urn:aaid:sc:AP:15870322-f1f4-4460-900c-6e056ab83a44 .
妊娠高血压疾病（HDP）对母婴健康构成重大威胁，全球范围内死亡率和发病率都很高，尤其是在发展中国家。子痫前期（PE）是产妇发病率和死亡率的重要原因，在印度等国家的不同地区，其发病率也有所不同。尽管取得了进展，但医疗保健获取方面的差距仍然存在，影响了结局。PE 不仅在妊娠期间影响产妇健康，还使妇女易患长期心血管并发症，强调需要早期筛查和预防措施。
本前瞻性随机双盲临床试验旨在比较 75mg 与 150mg 阿司匹林预防高危妇女早产子痫前期的疗效和安全性。将招募年龄在 18-45 岁之间、单胎妊娠 12-16 周的筛查阳性妇女。她们将以 1:1 的比例随机分为两组，每晚分别服用 75mg 或 150mg 阿司匹林，直至妊娠 37 周或出现早产子痫前期时提前停药。评估胎儿-产妇结局，包括早产子痫前期的发生率以及新生儿和产妇并发症。基于两组早产子痫前期预期比例的样本量计算表明，总共需要 370 名参与者（每组 185 名），预计失访率为 20%。
本前瞻性随机双盲临床试验旨在比较两种剂量阿司匹林（75mg 与 150mg）预防高危妇女早产子痫前期的有效性和安全性。这项研究的潜在意义重大，包括优化阿司匹林预防、制定基于证据的指南以及全面评估母婴结局。总之，这项研究的结果有可能通过改善母婴健康结局和促进基于证据的产科护理来显著影响临床实践。
印度临床试验注册中心 CTRI/2023/12/060983。试验于 2023 年 12 月 29 日前瞻性注册。注册号 REF/2023/12/076358。[网址]
