Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study (RFPTB)
2019年3月24日 更新者：Children's Hospital of Fudan University
The purpose of this study is to explore the perinatal risk factors of preterm birth in China.
研究概览
地位
完全的
条件
详细说明
Preterm birth is a global scourge, and the leading cause of newborn deaths (babies in the first 4 weeks of life) and raised to the leading cause of death among children under 5 years of age, responsible for approximately 1 million deaths in 2015.
In China, the prevalence of preterm increased from 4~5% in 1990s to 7~10% in 2010.
Preterm birth become a burden to both the family and society.
Therefore, the risk factors of preterm birth become the critical issue of both Obstetrics and Neonatology.
More importantly, few multicenter prospective studies on risk factors of preterm birth included potential reasons such as maternal occupation, psychology condition and lifestyles during pregnancy were conducted in China.
Thus, the aim of our study is to explore the perinatal risk factors of preterm birth nowadays in China.
研究类型
观察性的
注册 (实际的)
6000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Fujian
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Xiamen、Fujian、中国、361000
- Xiamen Maternal and Child Health Care Hospital
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Guangdong
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Guangzhou、Guangdong、中国、510260
- The Second Affiliated Hospital of Guangzhou Medical University
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Hainan
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Haikou、Hainan、中国、570206
- The Maternal and Child Health Hospital of Hainan Province
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Henan
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Zhengzhou、Henan、中国、450052
- The First Affiliated Hospital of Zhengzhou University
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Jiangsu
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Changzhou、Jiangsu、中国、213003
- Changzhou Maternal And Child Health Care Hospital
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Nanjing、Jiangsu、中国、210029
- Jiangsu Province Hospital
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Ningxia
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Wuzhong、Ningxia、中国、751300
- Tongxin County People's Hospital
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Yingchuan、Ningxia、中国、750001
- The First People's Hospital of Yinchuan
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Shandong
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Binzhou、Shandong、中国、256603
- Binzhou Medical University Hospital
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Jining、Shandong、中国、272011
- Jining No.1 People's Hospital
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Qingdao、Shandong、中国、266003
- Affiliated Hospital of Qingdao University
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Qingdao、Shandong、中国、266200
- Qingdao Jimo People's Hospital
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Shanghai
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Shanghai、Shanghai、中国、200011
- Obstetrics and Gynecology Hospital of Fudan University
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Shanghai、Shanghai、中国、201620
- Songjiang Maternity & Child Health Hospital of Shanghai
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Zhejiang
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Wenzhou、Zhejiang、中国、325600
- Yueqing Hospital Affiliated to Wenzhou Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 4周 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
Live-born preterm infants and one term infants born following the preterm infants in the same cooperation hospitals
描述
Inclusion Criteria:
- Live-born infants >20weeks of gestational age
Exclusion Criteria:
- Stillbirth
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Preterm group
All the live-born infants with gestational age less than 37weeks and more than 20weeks born in the cooperative hospital every day or every two or three days.
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Term group
The one next-live-born infants with gestational age at 37weeks or more than 37weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
live-born preterm
大体时间：at birth
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less than 37weeks gestational age
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at birth
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
birth weight (g)
大体时间：at birth
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Infant's weight recorded at the time of birth
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at birth
|
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gestation age (week)
大体时间：at birth
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the number of completed weeks of gestation, which was determined by the duration of menorrhoea or confirmed by an early ultrasound scan during pregnancy
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at birth
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Apgar score
大体时间：1min after birth
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determined by evaluating the newborn baby on five simple criteria（Appearance, Pulse, Grimace, Activity, Respiration） on a scale from zero to two, then summing up the five values thus obtained.
The resulting Apgar score ranges from zero to 10.
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1min after birth
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Apgar score
大体时间：5min after birth
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determined by evaluating the newborn baby on five simple criteria（Appearance, Pulse, Grimace, Activity, Respiration） on a scale from zero to two, then summing up the five values thus obtained.
The resulting Apgar score ranges from zero to 10.
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5min after birth
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small for gestational age
大体时间：at birth
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a birth weight below the 10th percentile for the gestational age
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at birth
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Chen Chao, PhD, MD、Children's Hospital of Fudan University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.
- Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11. Erratum In: Lancet. 2017 May 13;389(10082):1884.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月1日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2018年7月19日
首先提交符合 QC 标准的
2018年7月19日
首次发布 (实际的)
2018年7月27日
研究记录更新
最后更新发布 (实际的)
2019年3月26日
上次提交的符合 QC 标准的更新
2019年3月24日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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不
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