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

NCT ID: NCT01833559

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2021-08-31

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Incidence of GDM

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.

Group Type: OTHER

Dietary control

Intervention Type: DIETARY_SUPPLEMENT

Insulin

Intervention Type: DRUG

If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.

Gestational outcomes

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.

Group Type: OTHER

Dietary control

Intervention Type: DIETARY_SUPPLEMENT

Insulin

Intervention Type: DRUG

If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.

Metabolic disorder

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.

Group Type: OTHER

Dietary control

Intervention Type: DIETARY_SUPPLEMENT

Insulin

Intervention Type: DRUG

If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.

Interventions

Dietary control

Intervention Type: DIETARY_SUPPLEMENT

Insulin

If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.

Intervention Type: DRUG

Other Intervention Names

Novolin R; Novolin N; Novolin 30R; Novolin 50R

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zilian Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zilian Wang, Doctor

Role: CONTACT

zilianwang@gmail.com

13602885248 ext. +86

Facility Contacts

Zilian Wang, Doctor

Role: primary

zilianwang@gmail.com

13602885248 ext. +86

Other Identifiers

GDMTEST-5010-01

Identifier Type: REGISTRY

Identifier Source: secondary_id

GDMTEST-5010-02

Identifier Type: REGISTRY

Identifier Source: secondary_id

GDMTEST-5010-03

Identifier Type: REGISTRY

Identifier Source: secondary_id

GDMTEST-5010-04

Identifier Type: REGISTRY

Identifier Source: secondary_id

GDMTEST-5010-00

Identifier Type: -

Identifier Source: org_study_id