Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes

This study has been completed.
Sponsor:
Collaborators:
Tianjin Medical University
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Tianjin Women and Children's Health Center
ClinicalTrials.gov Identifier:
NCT01565564
First received: March 21, 2012
Last updated: November 26, 2013
Last verified: November 2013

March 21, 2012
November 26, 2013
September 2010
June 2013   (final data collection date for primary outcome measure)
The rate of macrosomia. [ Time Frame: At the time of birth. ] [ Designated as safety issue: No ]
Macrosomia is defined as birthweight ≥ 4000 gram.
Same as current
Complete list of historical versions of study NCT01565564 on ClinicalTrials.gov Archive Site
The rate of pregnancy-induced hypertension. [ Time Frame: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks. ] [ Designated as safety issue: No ]
Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.
Same as current
Not Provided
Not Provided
 
Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes
A Randomized Translational Study to Examine the Effects of Shared Care Versus Usual Care in Management of Gestational Diabetes in a Three-tier Prenatal Care Network in Tianjin, China

Research question (s)/hypothesis:

  1. . The effectiveness of the shared care management of gestational diabetes mellitus;
  2. . The cost-effectiveness of the shared care management;
  3. . Its sustainability

Method (s) Tianjin three-tier antenatal care network established a universal screening program for gestational diabetes mellitus (GDM) in 1998 and up to 2008, the screening program had screened 115348 pregnant women. GDM will be defined as either fasting plasma glucose (PG) ≥5.1 mmol/L or 1-hour PG≥ 10.0 mmol/L or 2-hour PG≥ 8.5 mmol/L after 75 g glucose tolerance test. A total of 920 pregnant women who have GDM and agree to participate will be randomly assign to have the shared care (diet, physical activity and insulin if indicated) or the local usual antenatal care. The sample size has ≥80% power at a 5% type I error to detect the difference in the primary endpoint, birth weight ≥4000 gram and the secondary endpoint, pregnancy-induced hypertension. Hyperglycemia and other clinical data in the two groups of women will be collected during the shared care or the usual care. Logistic regression and cost-effectiveness analysis will be used in the data analysis.

Public health significance: The introduction of the proven management of GDM in Tianjin antenatal care network will justify the universal screening for GDM and reduce the rate of macrosomic infants and reduce pregnancy-induced hypertension, and thus improve pregnancy outcomes of women with GDM.

Sustainability plan: Just as the universal GDM screening in 1998, the shared care model will be introduced into the Tianjin antenatal care network as part of the usual care routine after the proposed study. The success of the care model will also be publicized and expanded to suburban districts and rural counties of Tianjin, possibly other parts of world where universal screening for GDM is a routine practice.

ACKNOWLEDGEMENT This project is supported by a BRIDGES grant from the International Diabetes Federation. BRIDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes."

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Gestational Diabetes Mellitus
Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network
  • Individualized dietary and physical activity consultation plus group diabetes education
  • Self blood glucose monitoring
  • Insulin therapy if indicated
  • Self blood glucose monitoring
  • Insulin therapy institutions if indicated;
Other Name: The shared lifestyle intervention arm
  • Active Comparator: The usual care arm
    Intervention: Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network
  • Active Comparator: The shared care arm
    Intervention: Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
948
September 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All pregnant women who are diagnosed to have GDM.

Exclusion Criteria:

  • Diagnosis of overt diabetes during OGTT;
  • Younger than 18 years of age;
  • Non-singleton pregnancy;
  • Maternal-foetal ABO blood type incompatibility;
  • Maternal diseases such as chronic hypertension,thyrotoxicosis, prepregnancy diabetes and use of long-term medications that may affect glucose metabolism.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01565564
2009-02
Yes
Tianjin Women and Children's Health Center
Tianjin Women and Children's Health Center
  • Tianjin Medical University
  • Pennington Biomedical Research Center
Study Chair: Gongshu Liu, MD Women and Children's Health Center
Tianjin Women and Children's Health Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP