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
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.
- 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