ClinicalTrials.Veeva

Menu

Gut Microbiota, SCFAs and Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns

S

Second Affiliated Hospital of Wenzhou Medical University

Status

Unknown

Conditions

Gut Microbiota
Fetal Growth Restriction
Glucolipid Metabolism
Fetal Macrosomia

Treatments

Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity

Study type

Observational

Funder types

Other

Identifiers

NCT04399434
SAHoWMU-CR2020-07-209

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

120 participants in 3 patient groups

normal pregnancy
Description:
pregnancy with a normal fetal size
Treatment:
Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity
fetal growth restriction
Description:
fetal birth weight is below two standard deviations of the average weight for the same gestational age, or below the 10th percentile of normal weight for the same age
Treatment:
Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity
fetal macrosomia
Description:
fetal birth weight ≥ 4000g
Treatment:
Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity

Trial contacts and locations

1

Loading...

Central trial contact

Ying Hua

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems