Investigating microorganisms in pregnant women at risk for preterm birth
Investigation Into the Fungal Microbiome (Mycobiome) in the Cervices of Cervical Insufficiency Patients Receiving Cerclage Treatment and Resulting in Term or Preterm Birth
Chinese University of Hong Kong · NCT04688866
This study looks at the germs in the cervix of pregnant women who are at risk for preterm birth to see if there are differences between those with a short cervix and those with a normal one.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04688866 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pregnant women with a cervical length of less than 25 mm, who are at high risk for preterm birth. The researchers aim to identify differences in cervical microorganisms between women with cervical insufficiency and those with normal cervical length. Utilizing advanced molecular methods, including PCR amplification and next-generation sequencing, the study seeks to provide a comprehensive survey of microbial communities in the cervix. This approach aims to uncover potentially pathogenic microorganisms that may contribute to cervical insufficiency and preterm birth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a cervical length of less than 25 mm or those with a dilated cervix during the second trimester.
Not a fit: Patients with multiple pregnancies or those associated with fetal chromosomal abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of preterm birth risks in pregnant women.
How similar studies have performed: While there is emerging evidence linking cervical microorganisms to preterm birth, this study employs novel sequencing techniques that have not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with or without cervical insufficiency (cervical length \<25 mm or dilated cervix in the second trimester or the late first trimester) Exclusion Criteria: * multiple pregnancies and pregnancies associated with fetal chromosomal abnormality
Where this trial is running
Hong Kong
- Research Laboratory, Dept of Obstetrics & Gynaecology, The Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Stephen S Chim, PhD — Chinese University of Hong Kong
- Study coordinator: Stephen S Chim, PhD
- Email: sschim@cuhk.edu.hk
- Phone: (852)35051324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Insufficiency, Preterm Birth, preterm birth, cervical insufficiency, cerclage, pessary