Gestational Diabetes Mellitus (GDM)
Conditions
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
Interventions
BEHAVIORALlifestyle intervention with dietary and exercise recommendation
With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake.For example we suggested exchanging carbohydrate-rich foods with a medium-to-high glycaemic index for those with a lower glycaemic index to reduce the glycaemic load, and restricting dietary intake of saturated fat. With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed, or encourage them to do moderate cycling during pregnancy.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GDM | 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
| Measure | Time frame | Description |
|---|---|---|
| gestational weeks | up to 43 gestational weeks | record the gestational weeks for delivery |
| delivery mode | up to 43 gestational weeks | this includes vaginal delivery, operative vaginal delivery or cesarean delivery |
| macrosomia | up to 43 gestational weeks | birth weight above 4000.0 g |
| birth weight | up to 43 gestational weeks | birth weight measured after baby was delivered and accurate to 0.1 kg |
| SGA | up to 43 gestational weeks | birth weight below the 10th percentile for gestational age |
| gestational hypertention | up to 43 gestational weeks | defined as blood pressure elevation \[systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\] after 20 weeks gestation in the absence of proteinuria |
| pre-eclampsia | up to 43 gestational weeks | defined as new-onset hypertension \[systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\] and new-onset proteinuria \[300 mg of protein in 24 hours or a urine protein/creatinine ratio of 0.3 mg/dL\] after 20 weeks gestation or, in the absence of proteinuria, new-onset hypertension with new-onset thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual disturbances |
| LGA | up to 43 gestational weeks | birth weight above the 90th percentile for gestational age |
Countries
China
Contacts
Primary ContactChen Wang
Backup ContactYumei Wei
Outcome results
None listed