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

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

Study Overview

• Status: Completed
• Conditions: Risk Factors

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.

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Xiamen Maternal and Child Health Care Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University
  • Hainan
    • Haikou, Hainan, China, 570206
      • The Maternal and Child Health Hospital of Hainan Province
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Changzhou Maternal And Child Health Care Hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Ningxia
    • Wuzhong, Ningxia, China, 751300
      • Tongxin County People's Hospital
    • Yingchuan, Ningxia, China, 750001
      • The First People's Hospital of Yinchuan
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Binzhou Medical University Hospital
    • Jining, Shandong, China, 272011
      • Jining No.1 People's Hospital
    • Qingdao, Shandong, China, 266003
      • Affiliated Hospital of Qingdao University
    • Qingdao, Shandong, China, 266200
      • Qingdao Jimo People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Obstetrics and Gynecology Hospital of Fudan University
    • Shanghai, Shanghai, China, 201620
      • Songjiang Maternity & Child Health Hospital of Shanghai
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325600
      • Yueqing Hospital Affiliated to Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Live-born infants >20weeks of gestational age

Exclusion Criteria:

• Stillbirth

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
live-born preterm	less than 37weeks gestational age	at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
birth weight (g)	Infant's weight recorded at the time of birth	at birth
gestation age (week)	the number of completed weeks of gestation, which was determined by the duration of menorrhoea or confirmed by an early ultrasound scan during pregnancy	at birth
Apgar score	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.	1min after birth
Apgar score	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.	5min after birth
small for gestational age	a birth weight below the 10th percentile for the gestational age	at birth

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Chen Chao, PhD, MD, Children's Hospital of Fudan University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 24, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Premature birth; Risk factors
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: EKYYRFPTBMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No