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

• ClinicalTrials.gov Identifier: NCT03602625
• Recruitment Status: Completed
• First Posted: July 27, 2018
• Last Update Posted: March 26, 2019
• Sponsor: Children's Hospital of Fudan University
• Information provided by (Responsible Party): Children's Hospital of Fudan University

Study Description

Brief Summary:

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

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 6000 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: December 31, 2018
• Actual Study Completion Date: December 31, 2018

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. live-born preterm [ Time Frame: at birth ]
   less than 37weeks gestational age

Secondary Outcome Measures :

1. birth weight (g) [ Time Frame: at birth ]
   Infant's weight recorded at the time of birth
2. gestation age (week) [ Time Frame: 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
3. Apgar score [ Time Frame: 1min 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.
4. Apgar score [ Time Frame: 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.
5. small for gestational age [ Time Frame: at birth ]
   a birth weight below the 10th percentile for the gestational age

Eligibility Criteria

• Ages Eligible for Study: up to 28 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• Live-born infants >20weeks of gestational age

Exclusion Criteria:

• Stillbirth

Contacts and Locations

Locations

China, Fujian

Xiamen Maternal and Child Health Care Hospital

Xiamen, Fujian, China, 361000

China, Guangdong

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

China, Hainan

The Maternal and Child Health Hospital of Hainan Province

Haikou, Hainan, China, 570206

China, Henan

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

China, Jiangsu

Changzhou Maternal and Child Health Care Hospital

Changzhou, Jiangsu, China, 213003

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

China, Ningxia

Tongxin County People's Hospital

Wuzhong, Ningxia, China, 751300

The First People's Hospital of Yinchuan

Yingchuan, Ningxia, China, 750001

China, Shandong

Binzhou Medical University Hospital

Binzhou, Shandong, China, 256603

Jining NO.1 People's Hospital

Jining, Shandong, China, 272011

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266003

Qingdao Jimo People's Hospital

Qingdao, Shandong, China, 266200

China, Shanghai

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai, China, 200011

Songjiang Maternity & Child Health Hospital of Shanghai

Shanghai, Shanghai, China, 201620

China, Zhejiang

Yueqing Hospital Affiliated to Wenzhou Medical University

Wenzhou, Zhejiang, China, 325600

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

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

More Information

Additional Information:

A prospective multicenter epidemiology investigation of premature newborn 

Prevalence of singleton preterm birth in 10 cities of China in 1993-2005 

Publications:

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.

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.

• Responsible Party: Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT03602625
• Other Study ID Numbers: EKYYRFPTBMC
• First Posted: July 27, 2018
• Last Update Posted: March 26, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Fudan University:

Premature birth; Risk factors

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications