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Clinical Trials/NCT04399434
NCT04399434UnknownNot Applicable

Study on the Relationship of Gut Microbiota and Changes of SCFAs With Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns

Second Affiliated Hospital of Wenzhou Medical University1 site in 1 country120 target enrollmentStarted: January 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Gut Microbiota and SCFAs in mothers and their newborns

Study Overview

Brief Summary

Abnormal fetal size includes fetal growth restriction and fetal macrosomia. Onset is closely related to maternal nutrition metabolism. The specific correlation and mechanism is unclear, and there are no effective measures for early diagnosis and treatment. Previous study found that maternal gut microbiota participates in the material metabolism throughout the pregnancy. Insulin sensitivity in pregnant women, and intrauterine environment under abnormal blood glucose and lipid metabolism are important for the gut microbiota of newborns and even they grow up. However, changes in gut microbiota are the cause of the disease or the outcome is not yet clear. Short chain fatty acids (SCFAs) are produced from soluble dietary fibers in the diet by colon bacteriolysis. Studies have found that gut microbiota can regulate insulin sensitivity and glucose and lipid metabolism disorders through SCFAs. Therefore, this research group uses the gut microbiota as a new idea to studythe relationship of gut microbiota characteristics and level's change of SCFAs with glucolipid metabolism and insulin sensitivity in pregnant women with abnormal fetal size and their newborns through 16S-rRNA high-throughput sequencing, pyrosequencing, and gas chromatography-mass spectrometry, so we can reveal the role of gut microbiota in the pathogenesis of abnormal fetal size and explore targeted rational dietary adjustment and SCFAs reconstruction of gut microbiota to improve maternal and neonatal pregnancy outcomes.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Singleton pregnancy
  • Term pregnancy with the gestational age of 37-40 weeks

Exclusion Criteria

  • Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)
  • Delivery before 37 weeks or after 40 weeks
  • Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease)

Outcomes

Primary Outcomes

Gut Microbiota and SCFAs in mothers and their newborns

Time Frame: Stool samples from pregnant women with 37-40 gestational week and newborns within 3 days after birth

Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples

glucolipid metabolism and insulin sensitivity in pregnant women

Time Frame: Blood samples from pregnant women with 37-40 gestational week

glucolipid metabolism and insulin sensitivity in pregnant women with normal and abnormal fetal size

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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