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

NCT03602625 | Completed

• 1 other identifier: EKYYRFPTBMC
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Risk Factors

Keywords

Premature birth; Risk factors

Outcome Measures

Primary Outcomes (1)

• live-born preterm

  less than 37weeks gestational age

  at birth

Secondary Outcomes (5)

• birth weight (g)

  at birth

• gestation age (week)

  at birth

• Apgar score

  1min after birth

• Apgar score

  5min after birth

• small for gestational age

  at birth

Study Arms (2)

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.

Term group

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

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Live-born preterm infants and one term infants born following the preterm infants in the same cooperation hospitals

You may qualify if:

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

You may not qualify if:

• Stillbirth

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (15)

Xiamen Maternal and Child Health Care Hospital

Xiamen, Fujian, 361000, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

The Maternal and Child Health Hospital of Hainan Province

Haikou, Hainan, 570206, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Changzhou Maternal and Child Health Care Hospital

Changzhou, Jiangsu, 213003, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Tongxin County People's Hospital

Wuzhong, Ningxia, 751300, China

Location

The First People's Hospital of Yinchuan

Yingchuan, Ningxia, 750001, China

Location

Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China

Location

Jining NO.1 People's Hospital

Jining, Shandong, 272011, China

Location

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Qingdao Jimo People's Hospital

Qingdao, Shandong, 266200, China

Location

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Songjiang Maternity & Child Health Hospital of Shanghai

Shanghai, Shanghai Municipality, 201620, China

Location

Yueqing Hospital Affiliated to Wenzhou Medical University

Wenzhou, Zhejiang, 325600, China

Location

Related Publications (2)

• 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.

  PMID: 27839855 BACKGROUND

• 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.

  PMID: 22682464 BACKGROUND

Related Links

• A prospective multicenter epidemiology investigation of premature newborn
• Prevalence of singleton preterm birth in 10 cities of China in 1993-2005

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Chen Chao, PhD, MD

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

CN (15)