Clinical trial NCT03062475: Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus
Official title: The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 660
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: GDM
timeFrame: 24-28 gestational weeks
Secondary outcomes:
measure: birth weight
timeFrame: up to 43 gestational weeks
measure: gestational weeks
timeFrame: up to 43 gestational weeks
measure: delivery mode
timeFrame: up to 43 gestational weeks
measure: macrosomia
timeFrame: up to 43 gestational weeks
measure: LGA
timeFrame: up to 43 gestational weeks
measure: SGA
timeFrame: up to 43 gestational weeks
measure: gestational hypertention
timeFrame: up to 43 gestational weeks
measure: pre-eclampsia
timeFrame: up to 43 gestational weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking Unviersity First Hospital
name: Huixia Yang
role: STUDY_CHAIR
References: