Fetal Growth RestrictionNCT04399434
Gut Microbiota, SCFAs and Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns
An observational study of Fetal Growth Restriction and Gut Microbiota, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction, Gut Microbiota, Fetal Macrosomia
- What is being tested?
- test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants include mother-infant pairs meeting the inclusion criteria.
Who may be able to join
- Singleton pregnancy
- Term pregnancy with the gestational age of 37-40 weeks
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
ying hua, Doctor, 13676403165, wzfeyhy1015@126.com
About this study
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
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.
- Being tested
- test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity
- Medical subject headings
- Fetal Growth Retardation, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivityOther
test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers
| Study group | Role | What they receive |
|---|---|---|
| normal pregnancy | pregnancy with a normal fetal size Receives: 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 Receives: Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity | |
| fetal macrosomia | fetal birth weight ≥ 4000g Receives: Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Blood samples from pregnant women with 37-40 gestational week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jan 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Hua, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399434
- Sponsor's protocol ID
- SAHoWMU-CR2020-07-209
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04399434
- Acronym / sponsor ID
- SAHoWMU-CR2020-07-209
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal pregnancy | – | Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivitypregnancy with a normal fetal size |
| fetal growth restriction | – | Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivityfetal 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 |
| fetal macrosomia | – | Other: test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivityfetal birth weight ≥ 4000g |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants include mother-infant pairs meeting the inclusion criteria.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Term pregnancy with the gestational age of 37-40 weeks
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivitytest gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers | Other | fetal growth restriction, fetal macrosomia, normal pregnancy |
Primary outcome
Gut Microbiota and SCFAs in mothers and their newborns
Time frame: Stool samples from pregnant women with 37-40 gestational week and newborns within 3 days after birth
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
glucolipid metabolism and insulin sensitivity in pregnant women
Time frame: Blood samples from pregnant women with 37-40 gestational week
glucolipid metabolism and insulin sensitivity in pregnant women with normal and abnormal fetal size
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Hua study director
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction and Gut Microbiota, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Hua (+8613676403165 ext. +8613676403165, wzfeyhy1015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota and SCFAs in mothers and their newborns (time frame: Stool samples from pregnant women with 37-40 gestational week and newborns within 3 days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.