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Clinical trial

Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women

ID
Name
ThirdSunYat-senECII202329903
Description
This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them.
Trial arms
Trial start
2023-11-01
Estimated PCD
2025-10-01
Trial end
2025-10-01
Status
Recruiting
Treatment
Probiotic Blend Oral Tablet
In our study, forty pregnant women were randomly assigned to the probiotic group, and the rest were assigned to the control group. After enrollment, pregnant women in the probiotic group received a combination of living Bifidobacterium longum (5 #106 CFU) by Neimengu Shuangqi Pharmaceutical Co., Ltd. Pregnant individuals in the probiotic group were administered four tablets three times a day (2 g/d) for seven days before surgery until the fourth day after surgery.
Arms:
probiotics group
Size
80
Primary endpoint
analysis of postoperative recovery
12 months
16S rRNA amplicon sequencing of the V4 region
12 months
Eligibility criteria
Inclusion Criteria: * Chinese woman who is pregnant with a single fetus * Pregnant women who planned to perform lower section of uterus due to social factors, relative head basin asymmetry, macrosomia, cicatricial uterus and other reasons. Exclusion Criteria: * Gastrointestinal disease or family history * Antibiotic usage during pregnancy * Habit of eating foods with high probiotic content such as yogurt and cheese during pregnancy * Take other probiotics or probiotic drinks during pregnancy regularly * Hypertension, Diabetes Mellitus, Hyperthyroidism, Hypothyroidism, Autoimmune Disease, or Other Endocrine and Metabolic Disease * Transfusion History, Organ Transplantation History or Immunotherapy * Gestational hypertension, gestational diabetes, gestational thyroid dysfunction and other endocrine and metabolic diseases occurred during this pregnancy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-04-08

1 organization

1 product

2 indications

Organization
Third Affiliated Hospital, Sun Yat-Sen University
Product
Probiotic Blend
Indication
Microbiota
Indication
Postoperative Recovery