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

Risk Factors Clinical Trial

— RFPTB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602625
• Other study ID #: EKYYRFPTBMC
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Live-born infants >20weeks of gestational age

Exclusion Criteria:

• Stillbirth

Related Conditions & MeSH terms

• Premature Birth
• Risk Factors

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Changzhou Maternal and Child Health Care Hospital	Changzhou	Jiangsu
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Maternal and Child Health Hospital of Hainan Province	Haikou	Hainan
China	Jining NO.1 People's Hospital	Jining	Shandong
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Qingdao Jimo People's Hospital	Qingdao	Shandong
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	Tongxin County People's Hospital	Wuzhong	Ningxia
China	Xiamen Maternal and Child Health Care Hospital	Xiamen	Fujian
China	The First People's Hospital of Yinchuan	Yingchuan	Ningxia
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live-born preterm	less than 37weeks gestational age	at birth
Secondary	birth weight (g)	Infant's weight recorded at the time of birth	at birth
Secondary	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
Secondary	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
Secondary	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
Secondary	small for gestational age	a birth weight below the 10th percentile for the gestational age	at birth

External Links

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