NCT01565564

Brief Summary

Research question (s)/hypothesis:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
948

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 9, 2015

Completed
Last Updated

July 7, 2015

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

March 21, 2012

Results QC Date

May 21, 2015

Last Update Submit

June 9, 2015

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitusinterventionshared carepregnancy outcomemacrosomiapregnancy-induced hypertension

Outcome Measures

Primary Outcomes (1)

  • The Rate of Macrosomia.

    Macrosomia is defined as birthweight ≥ 4000 gram.

    At the time of birth.

Secondary Outcomes (1)

  • The Rate of Pregnancy-induced Hypertension.

    From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.

Study Arms (2)

The usual care arm

ACTIVE COMPARATOR
Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network

The shared care arm

ACTIVE COMPARATOR
Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network

Interventions

Shared glycaemic control care within the local three-tier's antenatal care networkBEHAVIORAL

* 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;

Also known as: The shared lifestyle intervention arm
The shared care armThe usual care arm

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All pregnant women who are diagnosed to have GDM.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Women and Children's Health Center

Tianjin, Tianjin Municipality, China

Location

Related Publications (2)

  • Li J, Liu J, Zhang C, Liu G, Leng J, Wang L, Li W, Yu Z, Hu G, Chan JCN, Yang X. Effects of Lifestyle Intervention of Maternal Gestational Diabetes Mellitus on Offspring Growth Pattern Before Two Years of Age. Diabetes Care. 2021 Mar;44(3):e42-e44. doi: 10.2337/dc20-2750. Epub 2021 Jan 25. No abstract available.

    PMID: 33495293DERIVED

  • Yang X, Tian H, Zhang F, Zhang C, Li Y, Leng J, Wang L, Liu G, Dong L, Yu Z, Hu G, Chan JC. A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes. J Transl Med. 2014 Oct 28;12:290. doi: 10.1186/s12967-014-0290-2.

    PMID: 25349017DERIVED

MeSH Terms

Conditions

Diabetes, GestationalHypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Limitations and Caveats

Exclusion of 242 women with GDM diagnosed from 10 Nov 2011 to 31 Jul 2012 due to potential contaminations due to logistic reasons.

Results Point of Contact

Title
Dr. Xilin Yang
Organization
Tianjin Medical University
yangxilin@tijmu.edu.cn
+86 22 83336727

Study Officials

  • Gongshu Liu, MD

    Women and Children's Health Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 28, 2012

Study Start

September 1, 2010

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

July 7, 2015

Results First Posted

June 9, 2015

Record last verified: 2015-06

Locations

CN(1)