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

NCT04399434 | Unknown DMC

• 1 other identifier: SAHoWMU-CR2020-07-209
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Growth Restriction; Gut Microbiota; Fetal Macrosomia; Glucolipid Metabolism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

normal pregnancy

pregnancy with a normal fetal size

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

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

fetal macrosomia

fetal birth weight ≥ 4000g

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

Interventions

test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity OTHER

test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers

fetal growth restriction; fetal macrosomia; normal pregnancy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Eligible participants is female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation; Fetal Macrosomia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ying Hua

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Ying Hua

CONTACT

+8613676403165; wzfeyhy1015@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: January 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

CN (1)