Preterm Birth Clinical Trial
Official title:
Investigation Into the Fungal Microbiome (Mycobiome) in the Cervices of Cervical Insufficiency Patients Receiving Cerclage Treatment and Resulting in Term or Preterm Birth
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Research Laboratory, Dept of Obstetrics & Gynaecology, The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Hallym University, Health and Medical Research Fund |
Hong Kong,
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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