Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04529889

GDM and Its Consequences in Mothers and Offsprings

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Weight in kilograms and height in meters were measured by nurses in clinic using standard tools. Weight and height will be combined to report BMI in kg/m^2. Childhood obesity is defined as a BMI equal to or larger than the 95th percentile for age by sex based on WHO Child Growth Standards.

Secondary outcomes

  1. Number of participants with adverse pregnancy outcomes

    Time frame: At delivery

    Including abortion, stillbirth, live birth, macrosomia, preterm birth, low birth weight, caesarean section delivery, and birth defects.

  2. Change of type 2 diabetes status in mothers

    Time frame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery

    Assessed by testing concentrations of maternal blood glucose.

  3. 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

    Assessed body composition using dual-energy X-ray absorptiometry.

  4. Change of depression symptom of mothers

    Time frame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery

    Using Edinburgh Postnatal Depression Scale and Self-rating Depression Scale to assess maternal depression. Higher score is considered more depressive.

  5. Change of neurodevelopment at early childhood

    Time frame: age of 6 weeks, 6 months, 1 year and 3 years.

    Assessed by Gesell Developmental Schedules and Ages&Stages Questionnaires which include adaptive, gross motor, fine motor, language, and social function domains. Higher intelligence quotient score in each domain is considered a better outcome. Intelligence quotient of Gesell Developmental Schedules being less than 86 or intelligence quotient of Ages&Stages Questionnaires being no more than -2SD under the mean is defined as suspected development retardation.

  6. Change of lung function during childhood and adolescence

    Time frame: At age of 6 years, 12 years and 18 years.

    Zrs, R5, R20, X5, X20, Fres assessed by impulse oscillometry

  7. 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.

    Eczema, allergic rhinitis, wheeze, and asthma diagnosed by the doctors or assessed by the standardized questionnaires

  8. Change of type 2 diabetes during childhood and adolescence

    Time frame: At age of 6 years, 12 years and 18 years.

    Assessed by testing concentrations of children's blood glucose.

Study contacts

Contact information is provided by the study sponsor or research team.

Songying Shen, MSc

CONTACT

0086 20 38367159

Xiu Qiu, MD,PhD

CONTACT

[email protected]

0086 20 38367160

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings

Acronym: GDMCMO

Important dates

Study start
2012
Primary completion
2038
Study completion
2038
First posted
Aug 28, 2020
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.