GDM and Its Consequences in Mothers and Offsprings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus, Pregnancy Outcome, Neurodevelopment, Immune Development. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings
Overview
Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term consequences for both mother and child. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery.
Detailed description
Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term consequences for both mother and child. Although maternal hyperglycemia often become normal shortly after pregnancy, women with GDM have crucially increased risk of development of type 2 diabetes later in life and the mechanisms are not fully understand. Systematic follow-up of the outcomes related to GDM would be ideal to observe the nature progression of GDM to diabetes and could help to develop preventable targets for intervention. The risks of obesity, the metabolic syndrome, and type 2 diabetes in offspring of mothers with GDM significantly increased 1-7 folds than those whose mothers didn't have GDM. The underlying pathogenic mechanisms behind the impaired metabolic risk profile and other diseases in offspring are unknown, but environmental changes including epigenetic changes induced by exposure to maternal hyperglycaemia and genetic factors may play essential roles. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery. We also aim to identify the high-risk population of mother-child pairs who are more likely to develop these adverse consequences, which might help to improve precise intervention and resource saving and provide evidence for preventable targets development.
Interventions
- Other
Primary outcome measures
- Change of obesity status during childhood and adolescence [Time frame: At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year]
Secondary outcome measures (8)
- Number of participants with adverse pregnancy outcomes [Time frame: At delivery]
- Change of type 2 diabetes status in mothers [Time frame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery]
- Change of body composition of mothers [Time frame: At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery]
- Change of depression symptom of mothers [Time frame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery]
- Change of neurodevelopment at early childhood [Time frame: age of 6 weeks, 6 months, 1 year and 3 years.]
- Change of lung function during childhood and adolescence [Time frame: At age of 6 years, 12 years and 18 years.]
- Change of Allergic diseases status during childhood and adolescence [Time frame: At age of 1 year, 3 years, 6 years, 12 years and 18 years.]
- Change of type 2 diabetes during childhood and adolescence [Time frame: At age of 6 years, 12 years and 18 years.]
Eligibility criteria
Inclusion criteria
- Pregnant women diagnosed with gestational diabetes mellitus
- Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their child for no less than 3 years
Exclusion criteria
- Women with pre-gestational diabetes mellitus
- Women with chronic hypertension or kidney disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangzhou Women and Children's Medical Center — Guangzhou
Publications
- Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20. PMID 28321694
- Shen S, Lu J, Zhang L, He J, Li W, Chen N, Wen X, Xiao W, Yuan M, Qiu L, Cheng KK, Xia H, Mol BWJ, Qiu X. Single Fasting Plasma Glucose Versus 75-g Oral Glucose-Tolerance Test in Prediction of Adverse Perinatal Outcomes: A Cohort Study. EBioMedicine. 2017 Feb;16:284-291. doi: 10.1016/j.ebiom.2017.01.025. Epub 2017 Jan 18. PMID 28122694
- Shen SY, Zhang LF, He JR, Lu JH, Chen NN, Xiao WQ, Yuan MY, Xia HM, Lam KBH, Qiu X. Association Between Maternal Hyperglycemia and Composite Maternal-Birth Outcomes. Front Endocrinol (Lausanne). 2018 Dec 11;9:755. doi: 10.3389/fendo.2018.00755. eCollection 2018. PMID 30619087
Identifiers
NCT: NCT04529889 · 201943701 · 81803251