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Clinical Trials/NCT03602625
NCT03602625
Completed
Not Applicable

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

Children's Hospital of Fudan University15 sites in 1 country6,000 target enrollmentStarted: January 1, 2018Last updated:
ConditionsRisk Factors

Overview

Phase
Not Applicable
Status
Completed
Enrollment
6,000
Locations
15
Primary Endpoint
live-born preterm

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Stillbirth

Outcomes

Primary Outcomes

live-born preterm

Time Frame: at birth

less than 37weeks gestational age

Secondary Outcomes

  • small for gestational age(at birth)
  • birth weight (g)(at birth)
  • gestation age (week)(at birth)
  • Apgar score(5min after birth)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (15)

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