Risk Factors of Preterm Birth Born in Hospital:a Prospective Multicenter Case-control Study

NCT ID: NCT03602625

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Risk Factors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Term group

The one next-live-born infants with gestational age at 37weeks or more than 37weeks.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Stillbirth
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen Chao, PhD, MD

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

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Xiamen Maternal and Child Health Care Hospital

Xiamen, Fujian, China

Site Status

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The Maternal and Child Health Hospital of Hainan Province

Haikou, Hainan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Changzhou Maternal and Child Health Care Hospital

Changzhou, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Tongxin County People's Hospital

Wuzhong, Ningxia, China

Site Status

The First People's Hospital of Yinchuan

Yingchuan, Ningxia, China

Site Status

Binzhou Medical University Hospital

Binzhou, Shandong, China

Site Status

Jining NO.1 People's Hospital

Jining, Shandong, China

Site Status

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Qingdao Jimo People's Hospital

Qingdao, Shandong, China

Site Status

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Songjiang Maternity & Child Health Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Site Status

Yueqing Hospital Affiliated to Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 27839855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22682464 (View on PubMed)

Related Links

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http://kns.cnki.net/KCMS/detail/detail.aspx?FileName=1013103173.nh&DbName=CDFD2013

A prospective multicenter epidemiology investigation of premature newborn

http://kns.cnki.net/KCMS/detail/detail.aspx?FileName=ZHLX200711005&DbName=CJFQ2007

Prevalence of singleton preterm birth in 10 cities of China in 1993-2005

Other Identifiers

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EKYYRFPTBMC

Identifier Type: -

Identifier Source: org_study_id

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