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Completed

NCT Number: NCT04420507

Gut and Oral Microbiome of GDM Patients During Pregnancy

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

The aims of the study are to reveal the possibly natural change of the gut and oral microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort study, the researchers will recruit pregnant women in early pregnancy(before 13 gestational weeks)and following the pregnancies till delivery. The stool samples and saliva samples of the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The investigators will also perform oral examination between 24~28 weeks and sample subgingival plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to analyze microbiome. And part of the samples of GDM patients will be analyzed using metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome between GDM patients and healthy women will be expected, as well as the natural change during pregnancy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the gut and oral microbiome of GDM patients during pregnancy

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

    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).

  2. the gut and oral microbiome of healthy pregnant women

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

    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).

Secondary outcomes

  1. The glucose level during pregnancy

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

    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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Chinese Academy of Medical Sciences

Registry information

Official study title

Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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