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

Not Applicable

• Conditions: Gestational Diabetes
• Interventions: Dietary Supplement: Dietary control; Drug: Insulin

• Registration Number: NCT01833559
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-14
• Study First Posted: 2013-04-17
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-16
• Last Update Posted: 2014-03-18
• Primary Completion: 2021-05
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incidence of GDM	Dietary control	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.
Incidence of GDM	Insulin	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.
Gestational outcomes	Dietary control	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.
Metabolic disorder	Dietary control	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.
Gestational outcomes	Insulin	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.
Metabolic disorder	Insulin	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.

Primary Outcome Measures

Name	Time	Method
The incidence of GDM at the second gestational trimester	at the second gestational trimester(about 24-28 gestational weeks)	The results of oral glucose tolerance test(OGTT) at the second gestational trimester(about 24-28 gestational weeks) which is used to diagnose GDM will be recorded to analysis the incidence of GDM at the second gestational trimester.

Secondary Outcome Measures

Name	Time	Method
Gestational outcomes	After delivery	The adverse gestational outcomes will be recorded. For example: GDM, preeclampsia,fetal growth restriction(FGR),and so on.

Trial Locations

Locations (1)

Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China