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| Name | Class |
|---|---|
| First People's Hospital of Foshan | OTHER |
| Jiangmen Maternity and Child Health Care Hospital | OTHER |
| Panyu Maternal And Child Care Service Centre Of Guangzhou | UNKNOWN |
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This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.
Women with early abnormal glucose metabolism (EAGM) , which is defined as fasting plasma glucose (FPG) 5.1-6.9 mmol/L and/or hemoglobin A1c (HbA1c) 5.7%-6.4% at before 14 weeks of gestation, will be recruited and randomized in a 1:1 ratio into the intervention or control group. The intervention will consist of a lifestyle intervention that comprises advice on diet, exercise, weight management and self-monitoring of blood glucose (SMBG) with feedback from healthcare professionals on results and insulin treatment if indicated. The educational session is delivered as an initial session following randomization followed by five follow-up sessions which will occur approximately every four months, either face-to-face during routine prenatal visits or via telephone consultation. Routine prenatal care will also be applied to the intervention group. Women in the control group will only receive routine prenatal care. Both groups will receive an OGTT test at 24-28 weeks of gestation unless insulin is needed before the OGTT test for suboptimally controlled blood glucose levels. Whether to continue the intervention depends on the OGTT results as women diagnosed with GDM or overt diabetes will continue intervention plus routine prenatal care until delivery while those will normal OGTT result will pause interventions and follow the routine prenatal care only until delivery. The primary outcome of our trial will be a composite of neonatal outcome including large-for-gestational age and preterm birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | The Intervention group will receive both intervention and routine prenatal care. |
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| control group | No Intervention | The control group will only receive routine prenatal care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention and self-monitoring of blood glucose | Behavioral | The intervention will consist of a lifestyle intervention that comprises advice on diet, exercise, weight management, and self-monitoring of blood glucose (SMBG) with feedback from healthcare professionals on results and insulin treatment if indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite neonatal outcome of large-gestational age and preterm birth | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy-related hypertensive disorders | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. | |
| Gestational diabetes mellitus | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haitian Chen, Professor | Contact | +8613763332296 | chhait@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yatsen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41796294 | Derived | Kong L, Shen L, Xie L, Li Z, Zhu C, Zhang S, Huang Y, Wang Z, Chen H. Effectiveness of a lifestyle intervention for pregnant women with abnormal glucose metabolism in early pregnancy (EAGM): protocol for a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial. BMC Pregnancy Childbirth. 2026 Mar 9;26(1):410. doi: 10.1186/s12884-026-08908-6. |
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| The Affiliated Shunde Hospital of Jinan University |
| UNKNOWN |
| Shenzhen Second People's Hospital | OTHER |
| BoAi Hospital of Zhongshan | OTHER |
| Yuebei People's Hospital | OTHER |
| Qingyuan People's Hospital | OTHER |
| The Sixth Affliated Hospital of Jinan University | UNKNOWN |
| Baoan Maternal And Child Health Care Hospital, Shenzhen, China | UNKNOWN |
| Jiangxi Maternal and Child Health Hospital | OTHER |
| Guangxi provincial maternal and chidren's hospital | UNKNOWN |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Obstetrics and Gynecology Hospital of Zhejiang University | UNKNOWN |
| Xiangya Hospital of Central South University | OTHER |
| Guangzhou Women's and Children's Hospital | UNKNOWN |
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| Gestational hypertension | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Preeclampsia | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Eclampsia | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Prescription of hypoglycaemic drug | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Preeclampsia requiring delivery before 37 weeks | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Total gestational weight gain | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Mode of birth | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Primary caesarean | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Large-for-gestational age | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Preterm birth at <37 weeks of gestation | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Neonatal birthweight | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Small-for-gestational-age | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Gestational age at birth, weeks and days | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Neonatal hypoglycaemia | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Admission to neonatal wards or intensive care unit | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Fetal loss <24 weeks of gestation | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Fetal loss ≥24 weeks of gestation | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Termination of pregnancy | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Neonatal death | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Apgar score at 1min after birth | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| Apgar score at 5min after birth | outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner. |
| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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