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| Name | Class |
|---|---|
| Tianjin Medical University | OTHER |
| Pennington Biomedical Research Center | OTHER |
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Research question (s)/hypothesis:
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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The usual care arm | Active Comparator |
| |
| The shared care arm | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared glycaemic control care within the local three-tier's antenatal care network | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Macrosomia. | Macrosomia is defined as birthweight ≥ 4000 gram. | At the time of birth. |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Pregnancy-induced Hypertension. | Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia. | From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gongshu Liu, MD | Women and Children's Health Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Women and Children's Health Center | Tianjin | Tianjin Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39010297 | Derived | Li J, Zhang R, Zhang C, Liu G, Li W, Wang H, Qiao Y, Yu Z, Hu G, Chan JCN, Leng J, Yang X. Effects of intensive treatment of Chinese women with gestational diabetes on the risk of offspring being overweight from 3 to 8 years of age. Diabetes Obes Metab. 2024 Sep;26(9):4126-4130. doi: 10.1111/dom.15770. Epub 2024 Jul 15. No abstract available. | |
| 33495293 |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Shared Care Arm | Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
| 25349017 | Derived | 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. |
| FG001 |
| The Usual Care Arm |
Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | The Usual Care Arm | Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
|
| BG001 | The Shared Care Arm | Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Rate of Macrosomia. | Macrosomia is defined as birthweight ≥ 4000 gram. | Posted | Number | participants | At the time of birth. |
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| ||||||||||||||||||||||||||||||
| Secondary | The Rate of Pregnancy-induced Hypertension. | Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia. | Posted | Number | participants | From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Shared Care Arm | Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
| 0 | 361 | 0 | 361 | ||
| EG001 | The Usual Care Arm | Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
| 0 | 339 | 0 | 339 |
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Exclusion of 242 women with GDM diagnosed from 10 Nov 2011 to 31 Jul 2012 due to potential contaminations due to logistic reasons.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xilin Yang | Tianjin Medical University | +86 22 83336727 | yangxilin@tijmu.edu.cn |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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