A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study
A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study
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DOI：
10.1186/s12884-017-1312-x
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发表时间：
2017-05-03
影响因子：
3.1
通讯作者：
Derman, Richard J.
中科院分区：
文献类型：
--
作者：
Hoffman, Matthew K.;Goudar, Shivaprasad S.;Derman, Richard J.
背景：早产（PTB）仍然是世界各地新生儿死亡和长期残疾的主要原因。虽然复杂的起源，越来越多的证据表明，在孕早期给予低剂量阿司匹林（LDA）可能会大大降低率PTB.Methods：假设：LDA开始在孕早期降低早产的风险。研究设计类型：在7个中低收入国家进行的前瞻性随机、安慰剂对照、双盲多国临床试验。试验将按照1：1的比例（干预/对照）进行单独随机化，人群：年龄在14至40岁之间的未生育女性，在入组前经超声证实胎龄（GA）在6 0/7周至13 6/7周之间的单胎妊娠，前三个月流产不超过两次，无阿司匹林禁忌症。干预措施：每日给予低剂量（81 mg）阿司匹林，在GA第6 0/7周和13 6/7周之间开始，并持续至GA第36 0/7周，与相同外观的安慰剂相比。将每两周评估一次依从性和结果。结果：主要结果：PTB的发生率（GA 37 0/7周之前出生）。次要结果先兆子痫/子痫的发病率，小于胎龄儿和围产期mortals.Discussion：这项研究是独一无二的，因为它将探讨LDA的影响，在低中收入国家的妊娠早期早产作为一个主要结果。在中低收入国家发展低成本、高影响的干预措施的重要性被放大，因为这些国家往往无法承担治疗疾病的财政费用。
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB.Methods: Hypothesis: LDA initiated in the first trimester reduces the risk of preterm birth. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multi-national clinical trial conducted in seven low and middle income countries. Trial will be individually randomized with one-to-one ratio (intervention/control) Population: Nulliparous women between the ages of 14 and 40, with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin. Intervention: Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.Outcomes: Primary outcome: Incidence of PTB (birth prior to 37 0/7 weeks GA). Secondary outcomes Incidence of preeclampsia/eclampsia, small for gestational age and perinatal mortality.Discussion: This study is unique as it will examine the impact of LDA early in pregnancy in low-middle income countries with preterm birth as a primary outcome. The importance of developing low-cost, high impact interventions in low-middle income countries is magnified as they are often unable to bear the financial costs of treating illness.