The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Sponsor
- Peking University First Hospital
- Enrollment
- 660
- Locations
- 1
- Primary Endpoint
- GDM
- Last Updated
- 6 years ago
Overview
Brief Summary
Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM.
Detailed Description
Gestational diabetes mellitus(GDM) is a commom complication during pregnancy. and the incidence has reached as high as 19.2% in China. GDM is associated with various adverse pregnancy outcomes for both the mother and her offspring, and not only during the perinatal phase, but also in the long term.Thus finding effective way to reduce the risk of GDM is of great importance,especial for women with high GDM risk factors. GDM history is one of the risk factors. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM
Investigators
Wang Chen
Principle investigator
Peking University First Hospital
Eligibility Criteria
Inclusion Criteria
- •Singleton;
- •non-smoking ;
- •before 12+6 weeks gestation.
Exclusion Criteria
- •less than 18 years old;
- •unwilling to provide informed consent;
- •cervical insufficiency;
- •women on any medication for pre-existing hypertension, diabetes, cardiac disease, renal disease, systemic lupus erythematosus, thyroid disease or psychosis;
- •women who were currently being treated with metformin or corticosteroids.
Outcomes
Primary Outcomes
GDM
Time Frame: 24-28 gestational weeks
According to the new criteria amended in August 2014 in China, GDM was diagnosed when any one value reaches or exceeds 5.1 mmol/L at 0 hours, 10.0 mmol/L at 1 hour, or 8.5 mmol/L at 2 hours. Values of 7.0 mmol/L at 0 hours or 11.1 mmol/L at 2 hours were diagnosed as DM, regardless of the pregnancy stage
Secondary Outcomes
- birth weight(up to 43 gestational weeks)
- delivery mode(up to 43 gestational weeks)
- macrosomia(up to 43 gestational weeks)
- LGA(up to 43 gestational weeks)
- SGA(up to 43 gestational weeks)
- gestational weeks(up to 43 gestational weeks)
- gestational hypertention(up to 43 gestational weeks)
- pre-eclampsia(up to 43 gestational weeks)