Actively Recruiting

Phase 1
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT06347770

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

Led by Zhe Li · Updated on 2026-04-15

404

Participants Needed

2

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Chinese woman who is pregnant with a single fetus
  • Pregnant women planning cesarean section due to social factors, relative head basin asymmetry, macrosomia, cicatricial uterus, or other reasons
Not Eligible

You will not qualify if you...

  • History of gastrointestinal disease or family history of gastrointestinal disease
  • Use of antibiotics during pregnancy
  • Habit of eating foods with high probiotic content such as yogurt and cheese during pregnancy
  • Regular intake of other probiotics or probiotic drinks during pregnancy
  • Hypertension, diabetes mellitus, hyperthyroidism, hypothyroidism, autoimmune disease, or other endocrine and metabolic diseases
  • History of blood transfusion, organ transplantation, or immunotherapy
  • Development of gestational hypertension, gestational diabetes, gestational thyroid dysfunction, or other endocrine and metabolic diseases during this pregnancy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The first affiliated hospital of Jinan University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

2

The third affiliated hospital of Sun Yat sen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

Z

Zhe Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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