Twin; Complicating PregnancyNCT03561766
Birth Cohort Study of China Medical University
An observational study of Twin; Complicating Pregnancy and Advanced Maternal Age Pregnancy, run by Shengjing Hospital at 1 site in China.
Trial summary
The CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin; Complicating Pregnancy, Advanced Maternal Age Pregnancy, Scarred Uterus
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to Jun 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women in Shenyang, China and their husband and children
Who may be able to join
- Pregnant women, <13 gestational weeks
- Permanent residents or families intended to remain in Shenyang and surrounding areas
- Pregnant women who are planned to be examined and delivered in Shengjing Hospital.
Who cannot join
- Pregnant women who refuse to take part in the study
- Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110004
Shaowei Yin, PhD, 86-18902458403, yinsw1984@163.com
Jiajin Hu, PhD, 86-18940287190, 495403966@qq.com
About this study
Official title: Birth Cohort Study of China Medical University in Shenyang
The CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental factors, family and lifestyle, clinical experimental outcomes and imaging results of pregnant women and children from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the children and their parents.
Read the detailed description
Early life phase (fetal and infant) is a critical period for the development of health and disease in a person's life. Many adult chronic diseases, such as diabetes, cardiovascular and cerebrovascular diseases, all come from the exposure of negative environmental and behavioral factors during this period. By collecting the lifestyle data and clinical data of pregnant women at different periods, the appropriate indicators are anticipated to be selected to predict and evaluate the outcome of pregnancy and the health of the mothers and children in the long term. The status of overweight and obesity of children in Shenyang and its surrounding areas are anticipated to be analyzed by descriptive and etiological analysis through collecting the lifestyle data and clinical data of different periods of pregnant women and the lifestyle data of different developmental stages of children.
- Conditions
- Twin; Complicating Pregnancy, Advanced Maternal Age Pregnancy, Scarred Uterus, Overweight and Obesity
- Medical subject headings
- Pregnancy Complications, Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age
Including head circumference, abdominal circumference, biparietal diameter, femur length of singleton and twin pregnancy
Measured: At every week from the thirteenth week of gestational age to delivery of babies
Weight in kilogram of neonate
Including singleton and twin pregnancy measured by nurses
Measured: At birth of neonate
Gene expression of husbands of pregnancy women
DNA methylation, histone acetylation etc. assessed by analyses of blood
Measured: At 13 weeks of gestational age
Change of gene expression of pregnancy women
DNA methylation, histone acetylation etc. assessed by analyses of blood
Measured: At 13, 26 and 34 weeks of gestational age
Result of Non-invasive Prenatal Testing
including singleton and twin pregnancy
Measured: From 12 to 22 weeks of gestational age
Secondary outcomes (4)
Change of intestinal flora during early childhood
Assessed by analyses of stool samples
Measured: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Height in centimeter changes during childhood
Measured by nurses in clinic
Measured: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Weight in kilogram changes during childhood
Measured by nurses in clinic
Measured: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Change of gene expression during childhood
DNA methylation, histone acetylation etc. assessed by analyses of blood
Measured: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start15 Jun 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2037 (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 Twin; Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caixia Liu, Shengjing Hospital
- Investigators
- Caixia Liu, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561766
- Sponsor's protocol ID
- CMUBCS
- Status last verified
- Dec 2019
- First submitted
- 21 May 2018
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Du Y, Zhou J, Liu C, Li J, Qiao C. Timing of diagnostic workups in Chinese population with recurrent pregnancy loss: a cross-sectional study. BMC Pregnancy Childbirth. 2025 Mar 29;25(1):373. doi: 10.1186/s12884-025-07330-8.
PubMed 40158174
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Cohort Study of China Medical University in Shenyang
- ClinicalTrials.gov ID
- NCT03561766
- Acronym / sponsor ID
- CMUBCS
- Conditions
- Twin; Complicating Pregnancy, Advanced Maternal Age Pregnancy, Scarred Uterus, Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 19 Jun 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 CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental factors, family and lifestyle, clinical experimental outcomes and imaging results of pregnant women and children from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the children and their parents.
Detailed description
Early life phase (fetal and infant) is a critical period for the development of health and disease in a person's life. Many adult chronic diseases, such as diabetes, cardiovascular and cerebrovascular diseases, all come from the exposure of negative environmental and behavioral factors during this period. By collecting the lifestyle data and clinical data of pregnant women at different periods, the appropriate indicators are anticipated to be selected to predict and evaluate the outcome of pregnancy and the health of the mothers and children in the long term. The status of overweight and obesity of children in Shenyang and its surrounding areas are anticipated to be analyzed by descriptive and etiological analysis through collecting the lifestyle data and clinical data of different periods of pregnant women and the lifestyle data of different developmental stages of children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women in Shenyang, China and their husband and children
Key inclusion criteria (3 listed)
- Pregnant women, <13 gestational weeks
- Permanent residents or families intended to remain in Shenyang and surrounding areas
- Pregnant women who are planned to be examined and delivered in Shengjing Hospital.
Key exclusion criteria (2 listed)
- Pregnant women who refuse to take part in the study
- Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.
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
Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age
Time frame: At every week from the thirteenth week of gestational age to delivery of babies
Including head circumference, abdominal circumference, biparietal diameter, femur length of singleton and twin pregnancy
Weight in kilogram of neonate
Time frame: At birth of neonate
Including singleton and twin pregnancy measured by nurses
Gene expression of husbands of pregnancy women
Time frame: At 13 weeks of gestational age
DNA methylation, histone acetylation etc. assessed by analyses of blood
Change of gene expression of pregnancy women
Time frame: At 13, 26 and 34 weeks of gestational age
DNA methylation, histone acetylation etc. assessed by analyses of blood
Result of Non-invasive Prenatal Testing
Time frame: From 12 to 22 weeks of gestational age
including singleton and twin pregnancy
4 secondary outcomes
Change of intestinal flora during early childhood
Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Height in centimeter changes during childhood
Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Weight in kilogram changes during childhood
Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Change of gene expression during childhood
Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 40158174Zhang L, Du Y, Zhou J, Liu C, Li J, Qiao C. Timing of diagnostic workups in Chinese population with recurrent pregnancy loss: a cross-sectional study. BMC Pregnancy Childbirth. 2025 Mar 29;25(1):373. doi: 10.1186/s12884-025-07330-8.
- Individual participant dataSharing planned: No
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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.
Caixia Liu principal investigator
Shengjing Hospital
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 Twin; Complicating Pregnancy and Advanced Maternal Age Pregnancy, run by Shengjing Hospital 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caixia Liu (86-18902451716, liucx1716@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age (time frame: At every week from the thirteenth week of gestational age to delivery of babies). The study lists 5 primary outcomes in all. 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 NCT03561766, 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 12 Dec 2019.