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Prospective cohort study on the relationship between pregnancy outcomes and characteristics of reproductive tract microbiome and gut microbiome of women with early threatened abortion

Prospective cohort study on the relationship between pregnancy outcomes and characteristics of reproductive tract microbiome and gut microbiome of women with early threatened abortion

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000041172
Enrollment
Unknown
Registered
2020-12-20
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

threatened miscarriage

Interventions

Threatened miscarriage group:No need
Normal pregnancy group:No need

Sponsors

The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for normal pregnancies are: (1) aged 18–45 years; (2)the menopause time is 4-8 weeks; (3)blood ß-hCG is positive, and the blood ß-hCG level is consistent with the gestational age; (4)Ultrasonography indicates normal intrauterine pregnancy and matches gestational ages; (5)no abortion symptoms such as vaginal bleeding or abdominal pain. The above (1) to (5) are required. Inclusion criteria for threatened abortion are: (1) aged 18–45 years; (2)the menopause time is 4-8 weeks; (3)blood ß-hCG is positive; (4)level of ß-HCG is not consistent with gestational ages; (5) vaginal bleeding with closed cervical os or abdominal pain; (6)Ultrasonography suggestes endometrial cavity fluid; (7)Ultrasonography suggestes weak embryonic heartbeat. The above (1) (2) (3) is a necessary condition, (4) ~ (7) meets one or more.

Exclusion criteria

Exclusion criteria: (1)Chromosomal abnormalities in either or both spouses; (2)Suffering from endocrine diseases,or autoimmune diseases,or infectious diseases, or inflammatory diseases of the gastrointestinal tract; or inflammatory diseases of the reproductive tract;or systemic inflammatory disease; or serious diseases of vital organs such as brain, liver, kidney, blood system, etc; or diagnosed with anxiety and depression; or anorexia nervosa; or with mental disorders and unable to cooperate; (3)Taking antibiotics or antifungal drugs or drugs that impair embryonic development or enema within 3 months; (4)sexual life, vaginal or cervical topical medication, or vaginal irrigation within 48 hours; (5)IUD placement status; (6)still in the last pregnancy and lactation period; (7)with excessive vaginal bleeding, which may affect the quality of the sample; (8)refuse to be followed up; (9)refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
ultrasound;serum hCG;serum progesterone;serum estradiol;

Secondary

MeasureTime frame
ph (vaginal secretion);leucocyte esterase (vaginal secretion);Vaginal discharge hydrogen peroxide;Vaginal secretions sialidase;Vaginal secretions beta-glucuronidase;Vaginal secretions Acetylglucosaminidase;

Countries

China

Contacts

Public ContactJie Gao

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

gjfkts@qq.com+86 13760605046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026