Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

Not Applicable

Not yet recruiting

• Conditions: PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
• Interventions: Dietary Supplement: aspirin 100mg and probiotics 1 bag

• Registration Number: NCT05554185
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-21
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 338

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	aspirin 100mg and probiotics 1 bag	aspirin 100mg and probiotics 1 bag
group B	aspirin 100mg and probiotics 1 bag	aspirin 100mg and placebo1 bag

Primary Outcome Measures

Name	Time	Method
The incidence of preeclampsia	From being recruited to 6 weeks after delivery	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of fetal growth restriction	From being recruited to 6 weeks after delivery	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