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Completed

NCT Number: NCT03602625

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

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

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Key information

Conditions

Risk Factors Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiamen Maternal and Child Health Care Hospital, Xiamen, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Live-born infants >20weeks of gestational age

Exclusion criteria

  • Stillbirth

Treatment and study plan

Primary outcomes

  1. live-born preterm

    Time frame: at birth

    less than 37weeks gestational age

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Acronym: RFPTB

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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