Clinical trial NCT01833559: Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study
Official title: Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is to investigate the impact of blood glucose management at the first trimester of pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic disorder.

Detailed description: Gestational diabetes(GDM) is the glucose metabolic disorder that first diagnosed during pregnancy. With the development of social economy and the improvement of life, the incidence of GDM increases to a level of 18-20% year by year. High blood glucose has a strong relationship with many adverse maternal and fetal outcomes, but also influences their metabolism including the increase of susceptibility of maternal type 2 diabetes and risk of fetal type 2 diabetes, obesity, coronary heart disease, etc. And therefore, it is significant to screening and managing maternal blood glucose to prevent maternal and fetal adverse outcomes and metabolic disorder.

This multi-central prospective cohort study is supposed to study the pregnant women whose fasting blood glucose is slightly increased (between 5.1 mmol/L and 7.0 mmol/L) at the first gestational trimester. The aim of this study is to answer the scientific questions bellow: whether interventions to whom the blood glucose is slightly increased can

1. decrease the incidence of GDM at the second gestational trimester;
2. improve gestational outcomes;
3. decrease the incidence of temporal and distant metabolic disorder of mother and her child.

The result will provide scientific evidence for improving the gestational outcomes of GDM women and preventing metabolic disorder of their child during adolescence and adult period.

Eligibility criteria: Inclusion Criteria:

* regular antenatal examination from the first trimester;
* accurate left mentoposterior(LMP) verified by ultrasonography(USG);
* fasting blood glucose level between 5.1 mmol/L and 7.0 mmol/L.

Exclusion Criteria:

* younger than 18 years old;
* do not give birth in the research centers above;
* LMP is undefined and lack of USG during 6-14 gestational weeks;
* multiple pregnancy;
* non-natural pregnancy(including intrauterine insemination(IUI), in-vitro fertilization and embryo transfer(IVF-ET), etc);
* diagnosed DM before pregnancy;
* with hepatitis B virus, hepatitis C virus, HIV infection;
* taking drugs including glucocorticoid, diuretic, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker(ACEI/ARB), etc.
* complicated with diseases that affect glucose metabolism such as hyperthyroidism and so on.

Primary outcomes:
measure: The incidence of GDM at the second gestational trimester
timeFrame: at the second gestational trimester(about 24-28 gestational weeks)
Secondary outcomes:
measure: Gestational outcomes
timeFrame: After delivery
Other outcomes:
measure: The incidence of temporal and distant metabolic disorder of mother
timeFrame: 2 months to 1 year after delivery
measure: Child growth measures
timeFrame: 2 months to 1 year after delivery
Locations:
city: Guangzhou
country: China
facility: Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: