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

Completed

• Conditions: Risk Factors

• Registration Number: NCT03602625
• Lead Sponsor: Children's Hospital of Fudan University

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-24
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Live-born infants >20weeks of gestational age

Exclusion Criteria

• Stillbirth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
live-born preterm	at birth	less than 37weeks gestational age

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Qingdao Jimo People's Hospital; 🇨🇳 Qingdao, Shandong, China

Tongxin County People's Hospital; 🇨🇳 Wuzhong, Ningxia, China

Jining NO.1 People's Hospital; 🇨🇳 Jining, Shandong, China

Xiamen Maternal and Child Health Care Hospital; 🇨🇳 Xiamen, Fujian, China

Changzhou Maternal and Child Health Care Hospital; 🇨🇳 Changzhou, Jiangsu, China

Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Songjiang Maternity & Child Health Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, China

Yueqing Hospital Affiliated to Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Maternal and Child Health Hospital of Hainan Province; 🇨🇳 Haikou, Hainan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The First People's Hospital of Yinchuan; 🇨🇳 Yingchuan, Ningxia, China

Binzhou Medical University Hospital; 🇨🇳 Binzhou, Shandong, China