Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Probiotic Supplementation During Pregnancy on Maternal and Infant Outcomes in Preeclampsia High-risk Groups Based on Abnormal Intestinal Flora: a Randomized Controlled Clinical Trial

Conditions
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PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy

Intervention / Treatment
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* Dietary Supplement: aspirin 100mg and probiotics 1 bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PE high-risk population aged 18-50 years with gut microbiota dysbiosis No severe cardiopulmonary diseases No severe hepatic and renal insufficiency No severe active infection Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism No diseases affecting intestinal microecology No history of smoking and drinking The researchers evaluated those pregnant women expected to deliver more than 20 weeks Voluntarily participate in this clinical study and sign the informed consent form Exclusion Criteria: With severe cardiopulmonary, hepatic and renal insufficiency With uncontrolled active infections 2 weeks before enrollment Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism with diseases affecting intestinal microecology Smoking and drinking history With acute gastrointestinal ulcer Hemorrhagic constitution Other discomfort assessed by the investigato

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>aspirin 100mg and probiotics 1 bag | Dietary Supplement: aspirin 100mg and probiotics 1 bag<br>* taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery.<br>|
| Placebo Comparator: group B<br>aspirin 100mg and placebo1 bag | Dietary Supplement: aspirin 100mg and probiotics 1 bag<br>* taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |