Impact of Blood Glucose at the First Trimester of Pregnant Women With

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01833559
Study type	Interventional
Source	First Affiliated Hospital, Sun Yat-Sen University
Contact	Zilian Wang, Doctor
Phone	13602885248
Email	zilianwang@gmail.com
Status	Recruiting
Phase	N/A
Start date	June 2012
Completion date	August 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms