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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorZhe Li

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Probiotic Blend Oral Tablet
  • Placebo Oral Tablet

Treatment groups

404 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zhe Li

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Sponsor institution