Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Obstetrics and Gynaecology, De Boelelaan 1117, Amsterdam, The Netherlands
Amsterdam Reproduction and Development, Amsterdam, The Netherlands.
BMJ Open. 2022 Aug 8;12(8):e060632. doi: 10.1136/bmjopen-2021-060632.
The use of low-dose aspirin by pregnant women to prevent preterm pre-eclampsia is gradually increasing. The administration of aspirin during pregnancy improves perinatal outcome, which could translate into improved child outcome in the long term. However, antenatal exposure to aspirin could have adverse effects on child development that may manifest later in life. The aim of this follow-up study is to assess the long-term effects of antenatal exposure to low-dose aspirin compared with placebo on survival, (neuro)development, behaviour and general health at 4 years corrected age.
This is a follow-up study of the Dutch double-blind randomised controlled APRIL trial which assessed the effectiveness of treatment with aspirin (80 mg daily) compared with placebo for the prevention of preterm birth in women with a previous spontaneous preterm birth. Treatment was initiated before 16 weeks of gestation and continued until 36 weeks or birth. We aim to follow-up all 379 children born to women who participated in the APRIL trial and survived the neonatal period, at the corrected age of 4 years. The main outcomes are (neuro)development as assessed by the Ages and Stages Questionnaire, and behaviour as assessed by the Strength and Difficulties Questionnaire. Additional outcomes include mortality, growth and general health from birth up to 4 years, and a composite outcome including mortality, abnormal (neuro)development and problem behaviour. Analyses will be performed by intention-to-treat using a superiority design.
Institutional Review Board approval was obtained from the Medical Research Ethics Committee from Amsterdam Medical Center (no. W20 289#20.325). The results will be published in a peer-reviewed journal and presented at conferences.
The APRIL trial (NTR5675, NL5553; EudraCT number 2015-003220-31) and the APRIL follow-up study (NL8950) are registered in the Dutch trial register. The study is funded by the Amsterdam Reproduction & Development research institute.
孕妇使用低剂量阿司匹林预防早产子痫前期的情况逐渐增多。怀孕期间使用阿司匹林可以改善围产期结局，这可能会在长期内转化为儿童结局的改善。然而，产前暴露于阿司匹林可能会对儿童的发育产生不良影响，这些影响可能会在以后的生活中显现出来。本随访研究的目的是评估与安慰剂相比，产前低剂量阿司匹林暴露对 4 岁校正年龄时的生存、（神经）发育、行为和一般健康的长期影响。
这是荷兰双盲随机对照 APRIL 试验的随访研究，该试验评估了在有自发性早产史的妇女中，用阿司匹林（每天 80 毫克）治疗与安慰剂治疗预防早产的效果。治疗在 16 周妊娠前开始，并持续到 36 周或分娩。我们的目标是随访所有参加 APRIL 试验并在新生儿期存活的 379 名妇女所生的儿童，在 4 岁的校正年龄时进行随访。主要结局是通过年龄和阶段问卷评估的（神经）发育，以及通过优势和困难问卷评估的行为。其他结局包括从出生到 4 岁的死亡率、生长和一般健康状况，以及包括死亡率、异常（神经）发育和问题行为的复合结局。分析将通过意向治疗进行，采用优效性设计。
阿姆斯特丹医学中心的医学研究伦理委员会获得了机构审查委员会的批准（编号为 W20 289#20.325）。结果将在同行评议的期刊上发表，并在会议上展示。
APRIL 试验（NTR5675，NL5553；EudraCT 编号 2015-003220-31）和 APRIL 随访研究（NL8950）均在荷兰试验注册处注册。该研究由阿姆斯特丹生殖与发育研究所资助。
