Gut and Oral Microbiome of GDM Patients During Pregnancy

NCT04420507 | Completed

• 1 other identifier: Gut and oral microbiome of GDM
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes; Pregnancy Related

Keywords

Gastrointestinal Microbiome; pregnancy; gestational diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• The glucose level during pregnancy

  the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)

Study Arms (2)

GDM group

pregnant women who are diagnosed after 75g OGTT test between 24\~27+6 gestational weeks

health group

pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pregnant women who can ensure a regular prenatal check in the PUMCH OB clinic.

You may qualify if:

• pregnant women
• gestational age: before 13+6 weeks
• regular prenatal care in PUMCH

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (4)

• 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.

  PMID: 28787280 RESULT

• 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(Suppl 1):3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26.

  PMID: 28447406 RESULT

• 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.

  PMID: 28252577 RESULT

• 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.

  PMID: 27814521 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool samples were collected from objects in 3 time points：the first trimester(9-14 gestational weeks), the second trimester(24-28 gestational weeks) and the third trimester(32-37 gestational weeks). All the samples were collected at home by the participants using a PSP Spin Stool DNA kit, and the genomic DNA was extracted. The researchers only amplified the hypervariable V4 region of the bacterial 16S rRNA genes.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: June 9, 2020
• Study Start: May 15, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)