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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Probiotic Blend Oral Tablet

    Drug

    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.

  • Placebo Oral Tablet

    Drug

    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.

Treatment groups

404 Participants
are divided into 2 treatment groups
Group A: probiotics groupExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

exhaust time

Time frame
DAY 4

Secondary outcomes

Other outcomes

Sponsors and contacts

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Zhe Li

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Sponsor institution