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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
  Purpose

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

Condition Intervention
Gestational Diabetes Mellitus
Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tianjin Women and Children's Health Center:

Primary Outcome Measures:
  • The rate of macrosomia. [ Time Frame: At the time of birth. ] [ Designated as safety issue: No ]
    Macrosomia is defined as birthweight ≥ 4000 gram.


Secondary Outcome Measures:
  • 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.


Enrollment: 948
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: The usual care arm 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 shared care arm 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

Detailed Description:

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."

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01565564

Locations
China, Tianjin
Tianjin Women and Children's Health Center
Tianjin, Tianjin, China
Sponsors and Collaborators
Tianjin Women and Children's Health Center
Tianjin Medical University
Pennington Biomedical Research Center
Investigators
Study Chair: Gongshu Liu, MD Women and Children's Health Center
  More Information

No publications provided

Responsible Party: Tianjin Women and Children's Health Center
ClinicalTrials.gov Identifier: NCT01565564     History of Changes
Other Study ID Numbers: 2009-02
Study First Received: March 21, 2012
Last Updated: November 26, 2013
Health Authority: China: Ministry of Health

Keywords provided by Tianjin Women and Children's Health Center:
Gestational diabetes mellitus
intervention
shared care
pregnancy outcome
macrosomia
pregnancy-induced hypertension

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on November 25, 2014