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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

Primary Purpose

Gestational Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dietary control
Insulin
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Incidence of GDM

Gestational outcomes

Metabolic disorder

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2013
Last Updated
March 16, 2014
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01833559
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incidence of GDM
Arm Type
Other
Arm Description
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.
Arm Title
Gestational outcomes
Arm Type
Other
Arm Description
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.
Arm Title
Metabolic disorder
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary control
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Novolin R, Novolin N, Novolin 30R, Novolin 50R
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of GDM at the second gestational trimester
Description
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.
Time Frame
at the second gestational trimester(about 24-28 gestational weeks)
Secondary Outcome Measure Information:
Title
Gestational outcomes
Description
The adverse gestational outcomes will be recorded. For example: GDM, preeclampsia,fetal growth restriction(FGR),and so on.
Time Frame
After delivery
Other Pre-specified Outcome Measures:
Title
The incidence of temporal and distant metabolic disorder of mother
Description
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.
Time Frame
2 months to 1 year after delivery
Title
Child growth measures
Description
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.
Time Frame
2 months to 1 year after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zilian Wang, Doctor
Phone
13602885248
Ext
+86
Email
zilianwang@gmail.com
Facility Information:
Facility Name
Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zilian Wang, Doctor
Phone
13602885248
Ext
+86
Email
zilianwang@gmail.com
First Name & Middle Initial & Last Name & Degree
Zilian Wang, Doctor

12. IPD Sharing Statement

Learn more about this trial

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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