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

Gestational Diabetes Clinical Trial

Official title:

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01833559
• Other study ID #: GDMTEST-5010-00
• Secondary ID: GDMTEST-5010-01G
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2013
• Last updated: March 16, 2014
• Start date: June 2012
• Est. completion date: August 2021

Study information

• Verified date: March 2014
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Zilian Wang, Doctor
• Phone: 13602885248
• Email: zilianwang[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: August 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Metabolic Diseases

Intervention

Dietary Supplement:
• Dietary control

Drug:
• 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.

Locations

Country	Name	City	State
China	Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of temporal and distant metabolic disorder of mother	After about 2 months after delivery when mother comes back for postpartum follow-up, some tests will be done, such as regular blood test,blood glucose(fasting and 2 hours after meal), urine regular test and so on.	2 months to 1 year after delivery	Yes
Other	Child growth measures	Children's body weight and height will be firstly recorded when their mothers come back for postpartum follow-ups at about 2 months after delivery by asking them or measure their children on the spot if they take their children with them.; And the growth measures of children will be recorded for the second time by asking them via telephone at about 1 year after delivery.	2 months to 1 year after delivery	Yes
Primary	The incidence of GDM at the second gestational trimester	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.	at the second gestational trimester(about 24-28 gestational weeks)	Yes
Secondary	Gestational outcomes	The adverse gestational outcomes will be recorded. For example: GDM, preeclampsia,fetal growth restriction(FGR),and so on.	After delivery	Yes