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

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

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 Overview

• Status: Unknown
• Conditions: Gut Microbiota; Fetal Macrosomia; Fetal Growth Restriction; Glucolipid Metabolism
• Intervention / Treatment: Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Ying Hua; Phone Number: +8613676403165 +8613676403165; Email: wzfeyhy1015@126.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
      • Contact: ying hua, Doctor; Phone Number: 13676403165; Email: wzfeyhy1015@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The participants include mother-infant pairs meeting the inclusion criteria.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal pregnancy; pregnancy with a normal fetal size	Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity; test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers
fetal growth restriction; 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	Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity; test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers
fetal macrosomia; fetal birth weight ≥ 4000g	Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity; test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiota and SCFAs in mothers and their newborns	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	Stool samples from pregnant women with 37-40 gestational week and newborns within 3 days after birth
glucolipid metabolism and insulin sensitivity in pregnant women	glucolipid metabolism and insulin sensitivity in pregnant women with normal and abnormal fetal size	Blood samples from pregnant women with 37-40 gestational week

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Body Weight; Fetal Diseases; Pregnancy Complications; Growth Disorders; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Fetal Growth Retardation; Fetal Macrosomia; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: SAHoWMU-CR2020-07-209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No