Gestational Diabetes Mellitus
Conditions
Keywords
Gestational diabetes mellitus, intervention, shared care, pregnancy outcome, macrosomia, pregnancy-induced hypertension
Brief summary
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
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.
Interventions
BEHAVIORALShared 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;
Sponsors
Tianjin Medical University
Pennington Biomedical Research Center
Tianjin Women and Children's Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Macrosomia. | At the time of birth. | Macrosomia is defined as birthweight ≥ 4000 gram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Pregnancy-induced Hypertension. | From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks. | Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
* Self blood glucose monitoring
* Insulin therapy if indicated
* Self blood glucose monitoring
* Insulin therapy institutions if indicated; | 361 |
| 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
* Self blood glucose monitoring
* Insulin therapy if indicated
* Self blood glucose monitoring
* Insulin therapy institutions if indicated; | 339 |
| Total | 700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
Baseline characteristics
| Characteristic | The Usual Care Arm | The Shared Care Arm | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 3.2 | 29.9 years STANDARD_DEVIATION 3.5 | 29.8 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 361 Participants | 339 Participants | 700 Participants |
| Race/Ethnicity, Customized Chinese | 361 Participants | 339 Participants | 700 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 361 Participants | 339 Participants | 700 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 361 participants | 339 participants | 700 participants |
| Sex: Female, Male Female | 361 Participants | 339 Participants | 700 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 361 | 0 / 339 |
| serious Total, serious adverse events | 0 / 361 | 0 / 339 |
Outcome results
Primary
The Rate of Macrosomia.
Macrosomia is defined as birthweight ≥ 4000 gram.
Time frame: At the time of birth.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Usual Care Arm | The Rate of Macrosomia. | 63 participants |
| The Shared Care Arm | The Rate of Macrosomia. | 38 participants |
Secondary
The Rate of Pregnancy-induced Hypertension.
Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.
Time frame: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Usual Care Arm | The Rate of Pregnancy-induced Hypertension. | 16 participants |
| The Shared Care Arm | The Rate of Pregnancy-induced Hypertension. | 27 participants |