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低分子肝素与西地那非治疗胎儿生长受限的随机、平行对照、开放标签临床试验

Maternal low molecular weight heparin versus sildenafil citrate for fetal growth restriction: a randomized, parallel groups, open-label clinical trial.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

出版信息

J Perinatol. 2020 May;40(5):715-723. doi: 10.1038/s41372-019-0544-1. Epub 2019 Nov 6.

DOI:10.1038/s41372-019-0544-1
PMID:31695136
Abstract

OBJECTIVES

To compare the effect of sildenafil citrate (SC) and low molecular weight heparin (LMWH) on neonatal birth weight (BW) and the fetoplacental blood flow in pregnancies with FGR.

STUDY DESIGN

A parallel groups, randomized clinical trial was conducted at a university hospital, between June 2017 and September 2018, involving 100 pregnant women with placental mediated FGR between 28 and 35 weeks of gestation who were randomly assigned to receive either SC or LMWH started at FGR diagnosis till delivery.

RESULTS

The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.

CONCLUSION

The neonatal BW, time from randomization to delivery, and fetoplacental blood flow indices were significantly better with LMWH use compared with SC.

摘要

目的

比较枸橼酸西地那非(SC)和低分子肝素(LMWH)对胎儿生长受限(FGR)孕妇新生儿体重(BW)和胎胎盘血流的影响。

研究设计

这是一项于 2017 年 6 月至 2018 年 9 月在一所大学医院进行的平行分组、随机临床试验,共纳入 100 例妊娠 28 至 35 周胎盘介导的 FGR 孕妇,随机分为 SC 组或 LMWH 组,从 FGR 诊断开始至分娩时接受治疗。

结果

LMWH 组新生儿 BW 高于 SC 组(p<0.000),随机分组至分娩的时间更长,LMWH 组的 UtA PI、UA PI 和 MCA PI 与 SC 治疗组相比有显著改善,p 值分别为 0.005、<0.000001 和 0.014。

结论

与 SC 相比,LMWH 可显著改善新生儿 BW、随机分组至分娩的时间以及胎胎盘血流指数。

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