Investigation Into the Microorganisms in Pregnant Women

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688866
• Other study ID #: 2012.243
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cervical Insufficiency
• Premature Birth
• Preterm Birth
• Uterine Cervical Incompetence

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