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

Sun Yat-sen University

Status: Unknown

Conditions: Gestational Diabetes

Treatments: Dietary Supplement: Dietary control; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01833559

GDMTEST-5010-02 (Registry Identifier)

GDMTEST-5010-04 (Registry Identifier)

GDMTEST-5010-03 (Registry Identifier)

GDMTEST-5010-01 (Registry Identifier)

GDMTEST-5010-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Incidence of GDM

Other group

Description:

Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.

Treatment:

Drug: Insulin

Dietary Supplement: Dietary control

Gestational outcomes

Other group

Description:

Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.

Treatment:

Drug: Insulin

Dietary Supplement: Dietary control

Metabolic disorder

Other group

Description:

Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.

Treatment:

Drug: Insulin

Dietary Supplement: Dietary control