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子宫内吸入与期待管理胎儿卵巢无回声囊肿:开放性随机对照试验。

In-utero aspiration vs expectant management of anechoic fetal ovarian cysts: open randomized controlled trial.

机构信息

Department of Obstetrics, Gynecology and Fetal Medicine, University Hospital of Tours, Tours, France.

Université François-Rabelais de Tours, Tours, France.

出版信息

Ultrasound Obstet Gynecol. 2018 Aug;52(2):159-164. doi: 10.1002/uog.18973. Epub 2018 Jul 4.

DOI:10.1002/uog.18973
PMID:29205608
Abstract

OBJECTIVE

To assess the efficacy and safety of in-utero aspiration (IUA) of anechoic fetal ovarian cysts.

METHODS

This multicenter, prospective, randomized open trial in two parallel groups included women from nine outpatient fetal medicine departments with singleton pregnancy ≥ 28 weeks of gestation and a female fetus with an ultrasound-diagnosed simple ovarian cyst, defined as a single fully anechoic cystic structure measuring ≥ 30 mm. They were allocated randomly to IUA under ultrasound guidance or expectant management. All procedures were performed by trained senior obstetricians. Primary outcome was need for neonatal intervention, by laparoscopy, laparotomy or transabdominal aspiration. Secondary outcomes were in-utero involution of the cyst and oophorectomy at birth. Analyses were conducted according to the intention-to-treat principle.

RESULTS

Of 61 participants, 34 were allocated to IUA and 27 to expectant management. Three IUA procedures (9%) could not be performed (one due to fetal position and two due to aspirations being dry). The remaining 31 IUA procedures were uneventful. The incidence of neonatal intervention did not differ significantly between the IUA and the expectant management groups (20.6% vs 37.0%; relative risk (RR), 0.55; 95% CI, 0.24-1.27). Nonetheless, IUA was associated with increased incidence of in-utero involution of the cyst (47.1% vs 18.5%; RR, 2.54; 95% CI, 1.07-6.05) and reduced rate of oophorectomy (3.0% vs 22.0%; RR, 0.13; 95% CI, 0.02-1.03) compared with expectant management.

CONCLUSION

IUA of anechoic fetal ovarian cysts, compared with expectant management, was not associated with a reduction in overall neonatal interventions but was associated with a reduced oophorectomy rate. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

摘要

目的

评估宫内抽吸(IUA)对无回声胎儿卵巢囊肿的疗效和安全性。

方法

本研究为多中心、前瞻性、随机开放临床试验,纳入来自 9 个妇产科门诊的 28 周以上单胎妊娠且经超声诊断为单纯卵巢囊肿的女性胎儿,囊肿定义为单一完全无回声囊性结构,直径≥30mm。随机分为超声引导下 IUA 组或期待管理组。所有操作均由资深产科医生进行。主要结局为新生儿需行腹腔镜、剖腹术或经腹抽吸术的干预。次要结局为宫内囊肿自然消退和出生时行卵巢切除术。分析遵循意向治疗原则。

结果

61 名参与者中,34 名被分配至 IUA 组,27 名被分配至期待管理组。3 次 IUA 操作(9%)无法进行(1 次因胎儿位置,2 次因抽吸物为干燥)。其余 31 次 IUA 操作均顺利完成。IUA 组和期待管理组新生儿干预的发生率无显著差异(20.6%比 37.0%;相对风险(RR),0.55;95%可信区间,0.24-1.27)。尽管如此,与期待管理组相比,IUA 组的囊肿宫内自然消退发生率更高(47.1%比 18.5%;RR,2.54;95%可信区间,1.07-6.05),卵巢切除术的发生率更低(3.0%比 22.0%;RR,0.13;95%可信区间,0.02-1.03)。

结论

与期待管理相比,IUA 治疗无回声胎儿卵巢囊肿并不会降低新生儿总体干预率,但可降低卵巢切除术的发生率。版权所有©2017 ISUOG。由 John Wiley & Sons Ltd 出版。

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