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| Name | Class |
|---|---|
| Quzhou Maternal and Child Health Care Hospital | UNKNOWN |
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Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT. |
|
| Placebo | Placebo Comparator | Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of gestational diabetes | The number of cases and incidence of gestational diabetes according to OGTT | 24-28th weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of macrosomia | macrosomia refers to a newborn weighs more than 4 kg) | Delivery |
| Weight gain during pregnancy (kg) | Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy |
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Inclusion Criteria:
Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danqing Chen, Prof | Contact | 86571-87061501 | Chendq@zju.edu.cn | |
| Xinning Chen | Contact | +8618817362544 | jhviolet@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office.
When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book.
If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
| Placebo | Dietary Supplement | placebo with similar appearance and smell but not containing probiotics |
|
| Delivery |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D019602 |
| Food and Beverages |