Preterm LaborNCT03210415
Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old
An observational study of Preterm Labor, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Observational Study Model
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Dec 2020
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese pregnant women ≥ 35 years old with spontaneous preterm birth between 28-37 weeks of gestation.
Who may be able to join
- Chinese pregnant women ≥ 35 years old
Who cannot join
- twins or multiple pregnancies, indicated preterm birth, <35 years old, gestational ages ≥ 37 weeks, incomplete data of prenatal care。
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affilliated Hospital of Chongqig Medical University
Chongqing, Chongqing Municipality, 400010
About this study
In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.
Read the detailed description
Because the policy of "Two-child" in China, there are more and more women more than 35 years old choose to have another baby. It is necessary to find out a way to prevent them who is older than 35 from preterm labor. About 1500 pregnant women will be recruited at about gestational age of 14 weeks for this study. All of them will be taken samples (i.e. blood, hair, cervical secretion ) to be saved before and after delivery. After all data collected, the investigators will do analysis of all data and find out strategy and mechanism of preterm labor.
- Conditions
- Preterm Labor
- Being tested
- Observational Study Model
- Keywords
- Preterm Labor, China, Pregnant Women, ≥35 Years Old
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study ModelOther
There is no intervention for the study.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Pregnant women ≥35 years old would have spontaneous preterm labor. There's no intervention in this group, because it's an Observational Study Model. Receives: Other: Observational Study Model | |
| Control group | Pregnant women ≥35 years old would not have spontaneous preterm labor. There's no intervention in this group, because it's an Observational Study Model. Receives: Other: Observational Study Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity of Preterm birth
Preterm delivery (PTD) is one of the most common and most serious complications of pregnancy. In China, preterm delivery is defined as delivery after 28 weeks completed but before 37 weeks of gestation. PTD rate varies between 5-18 %. Outcome also varies with the quality of neonatal care. create the highest burden for the society.
Measured: 1 years
Secondary outcomes (4)
Social Burden
Outcome varies with the quality of neonatal care. create the highest burden for the society. A 2006 report from the Institute of Medicine estimated the annual cost of preterm birth in the United States to be $26.2 billion or more than $51,000 per premature infant .
Measured: 1 years
Morbidity of Chorioamnionitis
The main hypothesis of the etiology of spontaneous PTD is ascending infection from the lower genital tract up in the sterile uterus invading the decidua, chorioamniotic membranes, amniotic fluid and, in some cases, the fetus. This is responsible for an inflammatory condition that might trigger myometrial contractions, rupture of the membranes and cervical maturation leading to PTD. Investigations have shown that the amount of bacteria present in the amniotic fluid is correlated to the level of intrauterine inflammation. Inflammation is also related to the presence of bacteria in the amniotic fluid and to histological chorioamnionitis.
Measured: 1 years
Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections
the short-term outcomes of the preterm delivery, which will cost money, time and source to beat. The treatment is not satisfactory, but create the highest burden for the society.
Measured: 1 years
Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation
the long-term outcomes of the preterm delivery. The main areas that are affected are the respiratory function and the neurodevelopment of these babies due to the early arrest in the lung and brain development, respectively. Moreover, the overall general health of this population is affected in the long-term and ongoing follow up studies are required to provide a better understanding in the field.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Peking University Third Hospital
- Responsible party
- Principal investigator, Hongbo Qi, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Hongbo bo Qi, Dr., Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210415
- Sponsor's protocol ID
- 2016YFC1000407
- Status last verified
- Oct 2019
- First submitted
- 4 May 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22682464
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old
- ClinicalTrials.gov ID
- NCT03210415
- Acronym / sponsor ID
- 2016YFC1000407
- Conditions
- Preterm Labor
- Keywords
- Preterm Labor, China, Pregnant Women, ≥35 Years Old
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Peking University Third Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 7 Jul 2017 (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.
In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.
Detailed description
Because the policy of "Two-child" in China, there are more and more women more than 35 years old choose to have another baby. It is necessary to find out a way to prevent them who is older than 35 from preterm labor. About 1500 pregnant women will be recruited at about gestational age of 14 weeks for this study. All of them will be taken samples (i.e. blood, hair, cervical secretion ) to be saved before and after delivery. After all data collected, the investigators will do analysis of all data and find out strategy and mechanism of preterm labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Observational Study ModelPregnant women ≥35 years old would have spontaneous preterm labor. There's no intervention in this group, because it's an Observational Study Model. |
| Control group | – | Other: Observational Study ModelPregnant women ≥35 years old would not have spontaneous preterm labor. There's no intervention in this group, because it's an Observational Study Model. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese pregnant women ≥ 35 years old with spontaneous preterm birth between 28-37 weeks of gestation.
Key inclusion criteria (1 listed)
- Chinese pregnant women ≥ 35 years old
Key exclusion criteria (1 listed)
- twins or multiple pregnancies, indicated preterm birth, <35 years old, gestational ages ≥ 37 weeks, incomplete data of prenatal care。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study ModelThere is no intervention for the study. | Other | Control group, Study group |
Primary outcome
Morbidity of Preterm birth
Time frame: 1 years
Preterm delivery (PTD) is one of the most common and most serious complications of pregnancy. In China, preterm delivery is defined as delivery after 28 weeks completed but before 37 weeks of gestation. PTD rate varies between 5-18 %. Outcome also varies with the quality of neonatal care. create the highest burden for the society.
4 secondary outcomes
Social Burden
Time frame: 1 years
Morbidity of Chorioamnionitis
Time frame: 1 years
Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections
Time frame: 1 years
Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Results publication: 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.
Hongbo bo Qi, Dr. principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Ministry of Science and Technology of the People´s Republic of China at 1 site 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: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Morbidity of Preterm birth (time frame: 1 years). 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 NCT03210415, which also lists 1 linked publication.
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 29 Oct 2019.