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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

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What is being tested

Dietary control

+ Insulin

+ Dietary control

Dietary SupplementDrug
Who is being recruted

Urogenital Diseases+6

+ Diabetes Mellitus

+ Endocrine System Diseases

From 18 to 60 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Study ContactZilian Wang, DoctorMore contacts
Last updated: March 18, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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 decrease the incidence of GDM at the second gestational trimester; improve gestational outcomes; 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.

NCT01833559
Principal SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Study ContactZilian Wang, DoctorMore contacts
Last updated: March 18, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMetabolic DiseasesNutritional and Metabolic DiseasesPregnancy ComplicationsGlucose Metabolism DisordersDiabetes, Gestational

Criteria

3 inclusion criteria required to participate
accurate left mentoposterior(LMP) verified by ultrasonography(USG)

fasting blood glucose level between 5.1 mmol/L and 7.0 mmol/L

regular antenatal examination from the first trimester

9 exclusion criteria prevent from participating
LMP is undefined and lack of USG during 6-14 gestational weeks

complicated with diseases that affect glucose metabolism such as hyperthyroidism and so on

diagnosed DM before pregnancy

do not give birth in the research centers above

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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 II

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 III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Guangzhou, ChinaOpen Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University in Google Maps
SuspendedOne Study Center