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Investigation Into the Microorganisms in Pregnant Women

NCT04688866 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-10-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hallym University

    collaborator OTHER

  • Health and Medical Research Fund

    collaborator OTHER_GOV

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Stephen S Chim, PhD · Chinese University of Hong Kong

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-05
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688866 on ClinicalTrials.gov