Clinical trial NCT03602625: Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study
Official title: Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factors
Keywords: Premature birth; Risk factors
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 6000
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Live-born preterm infants and one term infants born following the preterm infants in the same cooperation hospitals

Brief summary: The purpose of this study is to explore the perinatal risk factors of preterm birth in China.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Live-born infants \>20weeks of gestational age

Exclusion Criteria:

* Stillbirth

Primary outcomes:
measure: live-born preterm
timeFrame: at birth
Secondary outcomes:
measure: birth weight (g)
timeFrame: at birth
measure: gestation age (week)
timeFrame: at birth
measure: Apgar score
timeFrame: 1min after birth
measure: Apgar score
timeFrame: 5min after birth
measure: small for gestational age
timeFrame: at birth
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Maternal and Child Health Care Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Haikou
country: China
facility: The Maternal and Child Health Hospital of Hainan Province
state: Hainan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changzhou
country: China
facility: Changzhou Maternal and Child Health Care Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Wuzhong
country: China
facility: Tongxin County People's Hospital
state: Ningxia
city: Yingchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Jining
country: China
facility: Jining NO.1 People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Qingdao
country: China
facility: Qingdao Jimo People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Songjiang Maternity & Child Health Hospital of Shanghai
state: Shanghai
city: Wenzhou
country: China
facility: Yueqing Hospital Affiliated to Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Children's Hospital of Fudan University
name: Chen Chao, PhD, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.