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

NCT ID: NCT04399434

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Growth Restriction Gut Microbiota Fetal Macrosomia Glucolipid Metabolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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normal pregnancy

pregnancy with a normal fetal size

test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity

Intervention Type OTHER

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

test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity

Intervention Type OTHER

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

fetal macrosomia

fetal birth weight ≥ 4000g

test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Hua

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Wenzhou Medical University

Locations

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department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Hua

Role: CONTACT

+8613676403165 ext. +8613676403165

Facility Contacts

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ying hua, Doctor

Role: primary

13676403165

Other Identifiers

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SAHoWMU-CR2020-07-209

Identifier Type: -

Identifier Source: org_study_id

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