Probiotics before cesarean section to improve recovery in pregnant women
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
This study is testing if taking probiotics for a week before a cesarean section can help pregnant women recover faster after surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 404 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | Immunotherapy |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06347770 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of probiotics administered seven days prior to a cesarean section on the postoperative recovery of pregnant women. A total of 80 participants are divided into a control group and a probiotics group, with outcomes measured including anal exhaust time and first defecating time. Additionally, the study analyzes changes in gut microbiota through 16S rRNA amplicon sequencing. Participants are followed for seven days post-surgery to assess recovery.
Who should consider this trial
Good fit: Ideal candidates are Chinese women who are pregnant with a single fetus and scheduled for a cesarean section due to specific medical or social reasons.
Not a fit: Patients with gastrointestinal diseases, those who have used antibiotics during pregnancy, or those with certain metabolic or endocrine disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance postoperative recovery and gut health in pregnant women undergoing cesarean sections.
How similar studies have performed: While the use of probiotics in various contexts has shown promise, this specific approach in the context of cesarean recovery is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- The first affiliated hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)
- The third affiliated hospital of Sun Yat sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhe Li
- Email: mcal@foxmail.com
- Phone: +86-15521327083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.