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Comparative Analysis of Cross-Niche Microbiota in Pregnant Women with Gestational Diabetes Mellitus

Comparative Analysis of Cross-Niche Microbiota in Pregnant Women with Gestational Diabetes Mellitus: Microbial Characteristics, Functional Divergence, and Network Interactions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124160
Enrollment
Unknown
Registered
2026-05-08
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gestational diabetes mellitus

Interventions

Getational Diabets Mellitus group:None
Healthy control group:None

Sponsors

Sichuan Provincial Maternity and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy; 2. Aged 20–40 years; 3. Gestational age < 30 weeks at enrollment; 4. Registered medical records at the recruiting hospital with a plan to undergo regular antenatal care and delivery at the same institution; 5. Completed 75g Oral Glucose Tolerance Test (OGTT) between gestational weeks 24–28; 6. Willingness to comply with the study protocol and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pre-existing diabetes mellitus diagnosed prior to pregnancy; 2. Overt diabetes during pregnancy: Fasting plasma glucose =7.0 mmol/L, random plasma glucose =11.1 mmol/L, or HbA1c =6.5%; 3. Infectious or inflammatory conditions: Periodontitis, gingivitis, oral infections, acute gastroenteritis, inflammatory bowel disease, or other oral/gastrointestinal disorders within the past 3 months; 4. Medication interference: Use of antibiotics, probiotics, prebiotics, glucocorticoids, immunosuppressants, or other agents affecting microbiota within the past 1 month; 5. Comorbidities: Gestational hypertension, preeclampsia, thyroid disorders, autoimmune diseases, severe hepatic or renal dysfunction, malignant tumors, or other serious medical conditions; 6. Multiple or abnormal pregnancies: Multiple gestation, threatened abortion, fetal developmental abnormalities, or other conditions contraindicating study participation; 7. History of glucose metabolism disorders: Polycystic ovary syndrome (PCOS), Cushing's syndrome, or other conditions affecting blood glucose regulation; 8. Infectious diseases: Hepatitis B, Hepatitis C, HIV/AIDS, syphilis, or other communicable diseases; 9. Maternal lifestyle factors: Smoking or alcohol consumption during pregnancy; 10. Poor compliance or incomplete data: Inability to cooperate with sample collection/questionnaire completion, incomplete clinical documentation, or voluntary withdrawal from the study.

Design outcomes

Primary

MeasureTime frame
Alpha and beta diversity, community structure, functional divergence, and keystone taxa of oral, vaginal, gut, and placental microbiota across four body sites.;

Secondary

MeasureTime frame
glycemic excursion;

Countries

China

Contacts

Public ContactGao Yan

Sichuan Provincial Maternity and Child Health Care Hospital

290475126@qq.com+86 28 6587 8587

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026