The Effect of Oral Gan Shuangbi During the Perinatal Period on the Recovery of Intestinal Function After Cesarean Section in Pregnant Women- A Multicenter, Double-blind, Randomized Controlled Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic Blend Oral Tablet, Placebo Oral Tablet.
- Who it may be relevant to
- Registry conditions: Microbiota, Postoperative Recovery. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 202 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.
Interventions
- Drug Probiotic Blend Oral Tablet
In our study, 404 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. - Drug Placebo Oral Tablet
In our study, 404 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.
Primary outcome measures
- exhaust time [Time frame: DAY 4]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
China · 2 centers
- The first affiliated hospital of Jinan University — Guangzhou
- The third affiliated hospital of Sun Yat sen University — Guangzhou
Identifiers
NCT: NCT06347770 · ThirdSunYat-senECII202329903