Investigation Into the Microorganisms in Pregnant Women

NCT ID: NCT04688866

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-05
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Cervical Insufficiency; Preterm Birth

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pregnant women with cervical insufficiency (Cases)

Pregnant women with a shortened (\<25 mm) or dilated cervix in the second trimester (or late first trimester)

Sequencing

Intervention Type: OTHER

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.

Pregnant women without cervical insufficiency (Controls)

Pregnant women with a normal-length (\>= 25 mm) and closed cervix in the second trimester (or late first trimester)

Sequencing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hallym University

OTHER

Sponsor Role: collaborator

Health and Medical Research Fund

OTHER_GOV

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Stephen Chim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen S Chim, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Research Laboratory, Dept of Obstetrics & Gynaecology, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Stephen S Chim, PhD

Role: CONTACT

sschim@cuhk.edu.hk

(852)35051324

Karen K Wong, MPhil

Role: CONTACT

wkwkaren@cuhk.edu.hk

(852)

Facility Contacts

Stephen S Chim, PhD

Role: primary

sschim@cuhk.edu.hk

852-35051324

Wong K Karen, MPhil

Role: backup

wkwkaren@cuhk.edu.hk

852-23521798

Other Identifiers

2012.243

Identifier Type: -

Identifier Source: org_study_id