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Trial record 20 of 101 for:    Recruiting, Not yet recruiting, Available Studies | "Blood Glucose"

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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ClinicalTrials.gov Identifier: NCT01833559
Recruitment Status : Recruiting
First Posted : April 17, 2013
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Zilian Wang, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Dietary Supplement: Dietary control Drug: Insulin Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2012
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Other Names:
  • Novolin R
  • Novolin N
  • Novolin 30R
  • Novolin 50R

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.
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.
Other Names:
  • Novolin R
  • Novolin N
  • Novolin 30R
  • Novolin 50R

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.
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.
Other Names:
  • Novolin R
  • Novolin N
  • Novolin 30R
  • Novolin 50R




Primary Outcome Measures :
  1. The incidence of GDM at the second gestational trimester [ Time Frame: at the second gestational trimester(about 24-28 gestational weeks) ]
    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 :
  1. Gestational outcomes [ Time Frame: After delivery ]
    The adverse gestational outcomes will be recorded. For example: GDM, preeclampsia,fetal growth restriction(FGR),and so on.


Other Outcome Measures:
  1. The incidence of temporal and distant metabolic disorder of mother [ Time Frame: 2 months to 1 year after delivery ]
    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. Child growth measures [ Time Frame: 2 months to 1 year after delivery ]

    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.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833559


Contacts
Contact: Zilian Wang, Doctor 13602885248 ext +86 zilianwang@gmail.com

Locations
China, Guangdong
Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Zilian Wang, Doctor    13602885248 ext +86    zilianwang@gmail.com   
Principal Investigator: Zilian Wang, Doctor         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Zilian Wang, Doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01833559     History of Changes
Other Study ID Numbers: GDMTEST-5010-00
GDMTEST-5010-01 ( Registry Identifier: Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University )
GDMTEST-5010-02 ( Registry Identifier: Gynecology and obstetrics department of the 3rd affiliated hospital of Sun Yat-sen University )
GDMTEST-5010-03 ( Registry Identifier: Guangdong women and children hospital )
GDMTEST-5010-04 ( Registry Identifier: Guangzhou women and children hospital )
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs