Maternal and Fetal Medicine Unit, Obstetrics and Gynecology Department, Sant Pau University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain,
Maternal and Child Health and Development Network II (SAMID II) RD16/0022, Institute of Health Carlos III, Madrid, Spain,
Fetal Diagn Ther. 2020;47(11):824-833. doi: 10.1159/000509662. Epub 2020 Aug 25.
Preeclampsia (PE) and intrauterine growth restriction (IUGR) are major causes of maternal and perinatal morbidity and mortality. Previous studies have shown that intervention with low-dose aspirin resulted in a reduction in the occurrence of preterm PE. However, no data are currently available on the effect of low-molecular-weight heparin (LMWH) for the prevention of pregnancy complications in women enrolled at first trimester screening.
We aimed to assess the effectiveness of LMWH in the prevention of PE, IUGR, fetal death, and abruptio placentae in women classified as high risk based on their medical history and in women selected by first trimester screening of PE. Study -Design: This was a multicenter, randomized, open-label, parallel controlled trial in women without thrombophilia between 6.0 and 15.6 weeks of gestation. Inclusion criteria were severe PE or IUGR before 34 weeks of gestation and/or abruptio placentae or unexplained intrauterine death in a previous pregnancy; uterine artery mean pulsatility index Doppler >95th percentile and/or positive first trimester screening for PE. Pregnant women were randomly assigned to receive no intervention or LMWH until the 36th week of gestation. The primary composite outcome consisted of 1 or more of the following: development of PE, IUGR, abruptio placentae, and intrauterine fetal death.
A total of 278 pregnant women were randomly allocated to receive LMWH (n = 134) or no intervention (n = 144). Overall, 115 (41%) women experienced placental insufficiency complications, with no significant differences between the 2 arms: 50/144 (34.7%) in the LMWH arm and 43/134 (32%) in the control arm (p = 0.64, OR: 1.13, 95% CI: 0.68-1.85).
LMWH did not reduce the incidence of placenta-mediated complications either in women with previous adverse obstetric history without thrombophilia or in women selected by first trimester screening for PE. Based on these results, we cannot recommend the use of LMWH alone in women at risk of placental complications.
子痫前期（PE）和宫内生长受限（IUGR）是孕产妇和围产儿发病率和死亡率的主要原因。先前的研究表明，小剂量阿司匹林干预可降低早产 PE 的发生。然而，目前尚无数据显示低分子量肝素（LMWH）用于预防在孕早期筛查中入选的妇女的妊娠并发症的效果。
我们旨在评估 LMWH 在预防基于病史的高危妇女和 PE 孕早期筛查入选妇女的 PE、IUGR、胎儿死亡和胎盘早剥中的有效性。
这是一项在无血栓形成的 6.0 至 15.6 孕周的妇女中进行的多中心、随机、开放标签、平行对照试验。纳入标准为 34 周前严重 PE 或 IUGR 和/或既往妊娠中胎盘早剥或不明原因的宫内死亡；子宫动脉平均搏动指数多普勒>第 95 百分位数和/或 PE 孕早期筛查阳性。孕妇被随机分配接受无干预或 LMWH 治疗，直至 36 孕周。主要复合结局包括以下 1 项或多项：PE、IUGR、胎盘早剥和宫内胎儿死亡的发生。
共有 278 名孕妇被随机分配接受 LMWH（n = 134）或无干预（n = 144）。总体而言，115 名（41%）孕妇发生胎盘功能不全并发症，两组间无显著差异：LMWH 组 50/144（34.7%），对照组 43/134（32%）（p = 0.64，OR：1.13，95%CI：0.68-1.85）。
LMWH 并未降低无血栓形成的既往不良产科史妇女或 PE 孕早期筛查入选妇女胎盘介导并发症的发生率。基于这些结果，我们不能推荐单独使用 LMWH 治疗有胎盘并发症风险的妇女。
