Risk FactorsRFPTBNCT03602625
Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study
An observational study of Risk Factors, run by Children's Hospital of Fudan University at 15 sites in China.
Trial summary
The purpose of this study is to explore the perinatal risk factors of preterm birth in China. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Risk Factors
- How many people
- 6,000 participants
- Where
- 15 sitesChina
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Live-born preterm infants and one term infants born following the preterm infants in the same cooperation hospitals
Who may be able to join
- Live-born infants >20weeks of gestational age
Who cannot join
- Stillbirth
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
Changzhou Maternal and Child Health Care Hospital
Changzhou, Jiangsu, 213003
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
The Maternal and Child Health Hospital of Hainan Province
Haikou, Hainan, 570206
Jining NO.1 People's Hospital
Jining, Shandong, 272011
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Qingdao Jimo People's Hospital
Qingdao, Shandong, 266200
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Songjiang Maternity & Child Health Hospital of Shanghai
Shanghai, Shanghai Municipality, 201620
Yueqing Hospital Affiliated to Wenzhou Medical University
Wenzhou, Zhejiang, 325600
Tongxin County People's Hospital
Wuzhong, Ningxia, 751300
Xiamen Maternal and Child Health Care Hospital
Xiamen, Fujian, 361000
The First People's Hospital of Yinchuan
Yingchuan, Ningxia, 750001
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
The purpose of this study is to explore the perinatal risk factors of preterm birth in China.
Read the 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.
- Conditions
- Risk Factors
- Keywords
- Premature birth; Risk factors
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
live-born preterm
less than 37weeks gestational age
Measured: at birth
Secondary outcomes (5)
birth weight (g)
Infant's weight recorded at the time of birth
Measured: at birth
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
Measured: at birth
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.
Measured: 1min after birth
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.
Measured: 5min after birth
small for gestational age
a birth weight below the 10th percentile for the gestational age
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk FactorsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Chao, PhD, MD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602625
- Sponsor's protocol ID
- EKYYRFPTBMC
- Acronym
- RFPTB
- Status last verified
- Mar 2019
- First submitted
- 19 Jul 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27839855Blencowe 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.
PubMed 22682464
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study
- ClinicalTrials.gov ID
- NCT03602625
- Acronym / sponsor ID
- RFPTB / EKYYRFPTBMC
- Conditions
- Risk Factors
- Keywords
- Premature birth; Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Live-born preterm infants and one term infants born following the preterm infants in the same cooperation hospitals
Key inclusion criteria (1 listed)
- Live-born infants >20weeks of gestational age
Key exclusion criteria (1 listed)
- Stillbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
live-born preterm
Time frame: at birth
less than 37weeks gestational age
5 secondary outcomes
birth weight (g)
Time frame: at birth
gestation age (week)
Time frame: at birth
Apgar score
Time frame: 1min after birth
Apgar score
Time frame: 5min after birth
small for gestational age
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 27839855Liu 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.
- Background: PubMed 22682464Blencowe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Chao, PhD, MD study director
Children's Hospital of Fudan University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factors, run by Children's Hospital of Fudan University at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live-born preterm (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602625, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.