Effect of Oral Gan Shuangbi on Intestinal Recovery After Cesarean Section in Pregnant Women Multicenter, Double-blind, Randomized Controlled Phase 1 Trial

What this Trial Is About

Researchers are studying the effect of taking probiotics before a cesarean section on recovery and gut health in pregnant women. This trial focuses on how probiotics influence the time it takes for participants to pass gas and have their first bowel movement after surgery, which are key signs of recovery. A total of 202 pregnant women will be enrolled and divided into two groups for comparison. Participants will be randomly assigned to take either a probiotic oral tablet containing living Bifidobacterium longum or a placebo. Those in the probiotic group will take four tablets three times daily total 2 grams per day starting seven days before the cesarean section and continuing until four days after surgery. The study is double-blind and multicenter, with some participants receiving probiotics and others receiving placebo tablets. Throughout the study, researchers will monitor recovery by measuring the time to first gas release and first defecation. Participants will be followed for at least four days post-surgery to assess these outcomes. Safety and recovery progress will be tracked during this period. The total participation time spans from the week before the cesarean section through the four days after surgery.

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