孕36周与32周超声筛查胎儿生长受限：一项随机试验（ROUTE）

Ultrasound screening for fetal growth restriction at 36 vs 32 weeks' gestation: a randomized trial (ROUTE).

作者信息

Roma E, Arnau A, Berdala R, Bergos C, Montesinos J, Figueras F

机构信息

Obstetrics and Gynecology Department, Althaia, Network Healthcare Manresa Foundation, Barcelona, Spain.

Research and Innovation Unit, Althaia, Network Healthcare Manresa Foundation, Barcelona, Spain.

出版信息

Ultrasound Obstet Gynecol. 2015 Oct;46(4):391-7. doi: 10.1002/uog.14915.

DOI:10.1002/uog.14915

PMID:26031399

Abstract

OBJECTIVE

To compare the utility of routine third-trimester ultrasound examination at 36 weeks' gestation with that at 32 weeks in detecting fetal growth restriction (FGR).

METHODS

This was an open-label parallel randomized trial (ROUTE study) conducted at a single general hospital serving a geographically well-defined catchment area in Barcelona, Spain, between May 2011 and April 2014. Women with no adverse medical or obstetric history and a singleton pregnancy without fetal abnormalities at routine second-trimester scan were assigned randomly to undergo a scan at 32 weeks' gestation (n = 1272) or at 36 weeks' gestation (n = 1314). Primary outcome measures were detection rates of FGR (customized birth weight < 10(th) centile) and severe FGR (customized birth weight < 3(rd) centile).

RESULTS

There were no significant differences in perinatal outcome between those who underwent a scan at 32 weeks' gestation and those who underwent a scan at 36 weeks' gestation. Severe FGR at birth was associated significantly with emergency Cesarean delivery for fetal distress (odds ratio (OR), 3.4 (95% CI, 1.8-6.7)), neonatal admission (OR, 2.23 (95% CI, 1.23-4.05)), hypoglycemia (OR, 9.5 (95% CI, 1.8-49.8)) and hyperbilirubinemia (OR, 9.0 (95% CI, 4.6-17.6)). Despite similar false-positive rates (FPRs) (6.4% vs 8.2%), FGR detection rates were superior at 36 vs 32 weeks' gestation (sensitivity, 38.8% vs 22.5%; P = 0.006), with positive and negative likelihood ratios of 6.1 vs 2.7 and 0.65 vs 0.84, respectively. In cases of severe FGR, FPRs for both scans were also similar (8.5% vs 8.7%), but detection rates were superior at 36 vs 32 weeks' gestation (61.4% vs 32.5%; P = 0.008). Positive and negative likelihood ratios were 7.2 vs 3.7 and 0.4 vs 0.74, respectively.

CONCLUSION

In low-risk pregnancies, routine ultrasound examination at 36 weeks' gestation was more effective than that at 32 weeks' gestation in detecting FGR and related adverse perinatal and neonatal outcomes.

摘要

目的

比较妊娠36周与32周进行常规孕晚期超声检查在检测胎儿生长受限（FGR）方面的效用。

方法

这是一项开放标签平行随机试验（ROUTE研究），于2011年5月至2014年4月在西班牙巴塞罗那一家服务于地理区域明确的集水区的综合医院进行。无不良内科或产科病史且在常规孕中期扫描时单胎妊娠无胎儿异常的女性被随机分配在妊娠32周（n = 1272）或36周（n = 1314）进行扫描。主要结局指标为FGR（定制出生体重<第10百分位数）和严重FGR（定制出生体重<第3百分位数）的检出率。

结果

妊娠32周进行扫描的人群与妊娠36周进行扫描的人群围产期结局无显著差异。出生时严重FGR与因胎儿窘迫行急诊剖宫产（比值比（OR），3.4（95%CI，1.8 - 6.7））、新生儿入院（OR，2.23（95%CI，1.23 - 4.05））、低血糖（OR，9.5（95%CI，1.8 - 49.8））和高胆红素血症（OR，9.0（95%CI，4.6 - 17.6））显著相关。尽管假阳性率（FPR）相似（6.4%对8.2%），但妊娠36周时FGR的检出率高于32周（敏感性，38.8%对22.5%；P = 0.006），阳性似然比和阴性似然比分别为6.1对2.7和0.65对0.84。在严重FGR病例中，两次扫描的FPR也相似（8.5%对8.7%），但妊娠36周时的检出率高于32周（61.4%对32.5%；P = 0.008）。阳性似然比和阴性似然比分别为7.2对3.7和0.4对0.74。