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

June 9, 2015 updated by: Tianjin Women and Children's Health Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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."

Study Type

Interventional

Enrollment (Actual)

948

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Women and Children's Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • The shared lifestyle intervention arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Macrosomia.
Time Frame: At the time of birth.
Macrosomia is defined as birthweight ≥ 4000 gram.
At the time of birth.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Pregnancy-induced Hypertension.
Time Frame: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.
Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.
From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Women and Children's Health Center

Collaborators

Pennington Biomedical Research Center
Tianjin Medical University

Investigators

  • Study Chair: Gongshu Liu, MD, Women and Children's Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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