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评估辅助生殖技术受孕胎儿和婴儿的心血管重塑:一项前瞻性观察性队列研究方案

Assessing cardiovascular remodelling in fetuses and infants conceived by assisted reproductive technologies: a prospective observational cohort study protocol.

作者信息

Bi Wen-Jing, Cui Li, Xiao Yang-Jie, Song Guang, Wang Xin, Sun Lu, Qiao Wei, Ren Wei-Dong

机构信息

Department of Ultrasound, Shengjing Hospital of China Medical University, Shenyang, China.

Department of Ultrasound, Shengjing Hospital of China Medical University, Shenyang, China

出版信息

BMJ Open. 2019 Oct 28;9(10):e031452. doi: 10.1136/bmjopen-2019-031452.

Abstract

INTRODUCTION

Assisted reproductive technologies (ART), namely in vitro fertilisation and intracytoplasmic sperm injection, have become widely used to treat infertility. Although the use of ART is generally considered favourable, there are ongoing concerns about the prenatal and perinatal risks as well as long-term risks for the child. Epidemiological studies have demonstrated an association between pathological events during fetal development and future cardiovascular risk, raising concerns about cardiovascular remodelling in fetuses conceived by ART. The authors hypothesise fetuses conceived by ART present signs of cardioventricular dysfunction, which can be detected by deformation analysis. To address these issues, we will assess comprehensive cardiovascular structure and function in ART offspring and explore the role of speckle-tracking in myocardial deformation.

METHODS AND ANALYSIS

This prospective observational cohort study will include 100 singleton pregnancies conceived by ART and 100 controls identified in fetal life and followed up to 6 months old. At inclusion, a baseline assessment of the mothers and ART characteristics will be recorded by interview and review of medical records. Between 28 and 32 weeks gestation, a detailed fetal echography will be performed, including an assessment of estimated fetal weight, fetoplacental Doppler, fetal echocardiography and fetal abdominal artery ultrasound. On delivery, maternal and neonatal characteristics will be assessed. Within 60 days of birth, the first postnatal cardiovascular assessment will be conducted which will include echocardiography and abdominal artery ultrasound. At 6 months of age, the second infants' follow-up evaluation will include the weight and length of the infant, echocardiography and abdominal artery ultrasound. Data will be presented as mean±SD, median or percentages where appropriate. A p<0.05 will be considered statistically significant.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Ethics Committee of Shengjing Hospital of China Medical University. Findings will be disseminated through scientific publications and conference presentations.

TRIAL REGISTRATION NUMBER

ChiCTR1900021672.

摘要

引言

辅助生殖技术(ART),即体外受精和卵胞浆内单精子注射,已被广泛用于治疗不孕症。尽管ART的使用总体上被认为是有益的,但人们对产前和围产期风险以及儿童的长期风险仍存在担忧。流行病学研究表明,胎儿发育过程中的病理事件与未来心血管疾病风险之间存在关联,这引发了人们对ART受孕胎儿心血管重塑的担忧。作者推测,ART受孕胎儿存在心室功能障碍的迹象,可通过变形分析检测到。为解决这些问题,我们将评估ART后代的综合心血管结构和功能,并探索斑点追踪在心肌变形中的作用。

方法与分析

这项前瞻性观察队列研究将纳入100例ART受孕的单胎妊娠以及100例在胎儿期确定的对照,并随访至6个月龄。纳入时,将通过访谈和病历审查记录母亲和ART特征的基线评估。在妊娠28至32周期间,将进行详细的胎儿超声检查,包括估计胎儿体重、胎儿胎盘多普勒、胎儿超声心动图和胎儿腹主动脉超声评估。分娩时,将评估母亲和新生儿的特征。出生后60天内,将进行首次产后心血管评估,包括超声心动图和腹主动脉超声检查。在6个月龄时,第二次婴儿随访评估将包括婴儿的体重和身长、超声心动图和腹主动脉超声检查。数据将以均数±标准差、中位数或适当的百分比表示。p<0.05将被视为具有统计学意义。

伦理与传播

已获得中国医科大学盛京医院伦理委员会的伦理批准。研究结果将通过科学出版物和会议报告进行传播。

试验注册号

ChiCTR1900021672。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42a7/6830675/c5eebffb49e9/bmjopen-2019-031452f01.jpg

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