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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04688866
Other study ID # 2012.243
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2012
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Chinese University of Hong Kong
Contact Stephen S Chim, PhD
Phone (852)35051324
Email sschim@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pregnant women with short cervical length (<25 mm) in second-trimester ultrasonographic assessment are at high risk for preterm birth, a major cause of perinatal mortality and morbidity worldwide. Some of these short-cervix women proceed to a more advanced stage manifested as a painless prematurely dilated cervix in the second trimester. It is not fully understood why some women have short cervical length or prematurely dilated cervix (cervical insufficiency), although evidence is mounting that there is an association between short cervical length and infection by microorganisms. The investigators hypothesize that the cervical microorganisms in pregnant women with a shortened or dilated cervix are different, compared with those in women with normal cervical length and a closed cervix.


Description:

Previously, culture-dependent methods were used to detect bacterial or fungal infection, but the sensitivity was low, since not all species grew well in culture. Recently, molecular methods based on PCR amplification of the bacterial 16S ribosomal RNA (rRNA) gene or the fungal internal transcribed spacer (ITS) followed by capillary sequencing has been used to identify bacteria and fungi. However, the resolution of such capillary sequencing-based method (<100 sequencing reads/sample) is too low to capture the major collection of microorganisms in a sample. Less abundant but possibly pathogenic microorganisms associated with short cervical length remain undetectable. To address the current gap in this field, we propose to more comprehensively survey microbial communities in the cervix of pregnant women by PCR amplification of the 16S rRNA region, ITS or other genomic regions with taxonomic classification potential. This will be followed by next-generation sequencing (>40,000 sequencing reads/sample), which has been proven to capture the majority of microorganisms in a sample.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

Other:
Sequencing
This is an observational study, since the assignment of the medical intervention (e.g. cerclage or pessary) is not at the discretion of the investigator. However, cervical samples collected from both groups are subjected to amplicon sequencing for taxonomic classification of microorganisms.

Locations

Country Name City State
Hong Kong Research Laboratory, Dept of Obstetrics & Gynaecology, The Chinese University of Hong Kong Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
Chinese University of Hong Kong Hallym University, Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abundances of microorganisms in the cervix Abundances of microorganisms including bacteria and fungi in the cervix are measured by normalized sequencing read counts 1 year
Secondary Gestational age at delivery 1 year
Secondary Mode of delivery 1 year
Secondary Number of participants who received cerclage or ring pessary in the current pregnancy 1 year
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