Pregnancy Related Clinical Trial
Official title:
Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus
Verified date | March 2020 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM.
Status | Completed |
Enrollment | 163 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - pregnant women - gestational age: before 13+6 weeks - regular prenatal care in PUMCH Exclusion Criteria: - have medical history or current conditions: Gastrointestinal disorders, for example: Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD; - pregnant, combine with malignancy diseases; - pregnant, can't ensure regular prenatal check. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Chinese Academy of Medical Sciences |
China,
Edwards SM, Cunningham SA, Dunlop AL, Corwin EJ. The Maternal Gut Microbiome During Pregnancy. MCN Am J Matern Child Nurs. 2017 Nov/Dec;42(6):310-317. doi: 10.1097/NMC.0000000000000372. — View Citation
Jordan S, Baker B, Dunn A, Edwards S, Ferranti E, Mutic AD, Yang I, Rodriguez J. Maternal-Child Microbiome: Specimen Collection, Storage, and Implications for Research and Practice. Nurs Res. 2017 Mar/Apr;66(2):175-183. doi: 10.1097/NNR.0000000000000201. — View Citation
Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027. Review. — View Citation
Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017 Aug;12 Suppl 1:3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the gut and oral microbiome of GDM patients during pregnancy | The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). | the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks) | |
Primary | the gut and oral microbiome of healthy pregnant women | The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). | the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks) | |
Secondary | The glucose level during pregnancy | The fasting blood glucose level and the glycosylated albumin level in the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). And the result of 75gOGTT test. | the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks) |
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