Investigation Into the Microorganisms in Pregnant Women

NCT04688866 | Unknown

• 1 other identifier: 2012.243
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Insufficiency; Preterm Birth

Keywords

preterm birth; cervical insufficiency; cerclage; pessary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gestational age at delivery

  1 year

• Mode of delivery

  1 year

• Number of participants who received cerclage or ring pessary in the current pregnancy

  1 year

Study Arms (2)

Pregnant women with cervical insufficiency (Cases)

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

Other: Sequencing

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)

Other: Sequencing

Interventions

Sequencing 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 with cervical insufficiency (Cases); Pregnant women without cervical insufficiency (Controls)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who attend preterm clinics or receive antenatal care at the participating hospitals.

You may qualify if:

• Women with or without cervical insufficiency (cervical length \<25 mm or dilated cervix in the second trimester or the late first trimester)

You may not qualify if:

• multiple pregnancies and pregnancies associated with fetal chromosomal abnormality

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hallym University: collaborator
• Health and Medical Research Fund: collaborator

Study Sites (1)

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

Hong Kong, 852, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cervical swab samples obtained comprise ample amount of DNA for PCR amplification or sequencing.

MeSH Terms

Conditions

Uterine Cervical Incompetence; Premature Birth

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Stephen S Chim, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen S Chim, PhD

CONTACT

(852)35051324; sschim@cuhk.edu.hk

Karen K Wong, MPhil

CONTACT

(852); wkwkaren@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 30, 2020
• Study Start: June 5, 2012
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)