Clinical trial NCT04399434: Gut Microbiota, SCFAs and Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns
Official title: Study on the Relationship of Gut Microbiota and Changes of SCFAs With Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Restriction
Gut Microbiota
Fetal Macrosomia
Glucolipid Metabolism
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants include mother-infant pairs meeting the inclusion criteria.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Gut Microbiota and SCFAs in mothers and their newborns
timeFrame: Stool samples from pregnant women with 37-40 gestational week and newborns within 3 days after birth
measure: glucolipid metabolism and insulin sensitivity in pregnant women
timeFrame: Blood samples from pregnant women with 37-40 gestational week
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Ying Hua
role: STUDY_DIRECTOR
References: