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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03602625

Acronym

RFPTB

Enrollment

6000

Registered

2018-07-27

Start date

2018-01-01

Completion date

2018-12-31

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Factors

Keywords

Premature birth; Risk factors

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Stillbirth

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	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.
small for gestational age	at birth	a birth weight below the 10th percentile for the gestational age

Countries

China

Outcome results