跳至主要内容
临床试验/NCT05674214
NCT05674214已完成不适用

Occurrence of Liveborn Twins With Birth Weight-discordance and Its Relationship to the Adverse Outcomes: a Multicenter Retrospective Study

The Third Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 13,440 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13,440
试验地点
1
主要终点
neonatal complications

研究概览

简要总结

The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries. There are significant differences in birth weight of some newborns, that is, birth weight-discordance in twin pregnancies (BWDT). BWDT was significantly associated with fetal death, preterm birth, neonatal death, and neonatal complications. Existing studies mainly focus on the perinatal outcomes of mothers and infants with BWDT, or are reported from small samples in developed countries. The investigators are aware of the need to further explore the occurrence of birth weight inconsistency and adverse neonatal outcomes in China with a large sample. Through retrospective study design, the investigators will collect clinical data of live twin births at multiple study sites, investigate the incidence of BWDT, and analyze its adverse outcomes.

详细描述

The investigators adopted a multicenter retrospective case-control study design and enrolled live twin births delivered from 2018 to 2020 in 22 hospitals in 12 provinces in China. Children with congenital and hereditary diseases, such as inherited metabolic diseases, complex congenital heart disease, and digestive tract malformations, were excluded from the study. The investigators collected the following information: (1) General information: maternal age, year of delivery, number of delivery, mode of conception, mode of delivery, chorionic nature, education level, newborn sex; (2) Maternal risk factors associated with intrauterine development: induced abortion ≥2 times, placental disease, uterine tumor, gestational diabetes mellitus, gestational hypertension disease, intrahepatic cholestasis, connective tissue disease, hypothyroidism, and chorionic amnitis; (3) Infant birth outcome: gestational age, birth weight, birth length, birth head circumference, very low birth weight infants, ultra-low birth weight infants, the Apgar score, whether transferred to neonatology department. (4) Information of hospitalization during the neonatal period: Pulmonary surfactant use, duration of oxygen therapy, neonatal complications (i.e., pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc.), feeding status (i.e., duration of milk opening, duration of full feeding, feeding style and feeding materials at full feeding, Time to recovery of birth weight), and discharge outcome (i.e., total hospitalization cost, length of stay, gestational age corrected for discharge, discharge status, discharge physique).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • live twin births
  • delivered from 2018 to 2020

排除标准

  • congenital and hereditary diseases
  • inherited metabolic diseases
  • complex congenital heart disease
  • digestive tract malformations

结局指标

主要结局

neonatal complications

时间窗: 1 month

the morbidity of pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc

birth outcome

时间窗: 1 day

gestational age

次要结局

  • discharge outcome(3 months)

研究者

发起方
The Third Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Birth Weight-discordance in Twins Pregnancy: a... | 临床试验