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In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | aspirin 100mg and probiotics 1 bag |
|
| group B | Placebo Comparator | aspirin 100mg and placebo1 bag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin 100mg and probiotics 1 bag | Dietary Supplement | taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of preeclampsia | After 20 weeks of pregnancy, systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg, accompanied by any of the following items: urinary protein ≥ 0.3g/24h, or urinary protein / creatinine ratio ≥ 0.3,or random urinary protein ≥ (+) (examination method for unconditional protein quantification); Non-albuminuria can be accompanied by any kind of organ or system involvement: heart, lung, liver, kidney and other important organs, or abnormal changes in blood system, digestive system, nervous system, placenta-fetus, etc. | From being recruited to 6 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of fetal growth restriction | due to the influence of pathological factors such as mother, fetus and placenta, fetal growth does not reach its due genetic potential, which is characterized by fetal body weight or abdominal circumference estimated by ultrasound lower than the 10th percentile of the corresponding gestational age | From being recruited to 6 weeks after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yichi Zhang | Contact | 18774562132 | 1525683944@qq.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31900289 | Result | Chen X, Li P, Liu M, Zheng H, He Y, Chen MX, Tang W, Yue X, Huang Y, Zhuang L, Wang Z, Zhong M, Ke G, Hu H, Feng Y, Chen Y, Yu Y, Zhou H, Huang L. Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation. Gut. 2020 Mar;69(3):513-522. doi: 10.1136/gutjnl-2019-319101. Epub 2020 Jan 3. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |