Cervical InsufficiencyNCT04688866
Investigation Into the Microorganisms in Pregnant Women
An observational study of Cervical Insufficiency and Preterm Birth, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Insufficiency, Preterm Birth
- What is being tested?
- Sequencing
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jun 2012to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who attend preterm clinics or receive antenatal care at the participating hospitals.
Who may be able to join
- Women with or without cervical insufficiency (cervical length <25 mm or dilated cervix in the second trimester or the late first trimester)
Who cannot join
- multiple pregnancies and pregnancies associated with fetal chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Research Laboratory, Dept of Obstetrics & Gynaecology, The Chinese University of Hong Kong
Hong Kong, 852
Stephen S Chim, PhD, 852-35051324, sschim@cuhk.edu.hk
Wong K Karen, MPhil, 852-23521798, wkwkaren@cuhk.edu.hk
About this study
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
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.
Read the 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
- Being tested
- Sequencing
- Keywords
- preterm birth, cervical insufficiency, cerclage, pessary
- Medical subject headings
- Uterine Cervical Incompetence, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SequencingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with cervical insufficiency (Cases) | Pregnant women with a shortened (<25 mm) or dilated cervix in the second trimester (or late first trimester) Receives: 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) Receives: Other: Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abundances of microorganisms in the cervix
Abundances of microorganisms including bacteria and fungi in the cervix are measured by normalized sequencing read counts
Measured: 1 year
Secondary outcomes (3)
Gestational age at delivery
Measured: 1 year
Mode of delivery
Measured: 1 year
Number of participants who received cerclage or ring pessary in the current pregnancy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start5 Jun 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical InsufficiencyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University, Health and Medical Research Fund
- Responsible party
- Principal investigator, Stephen Chim, Chinese University of Hong Kong
- Investigators
- Stephen S Chim, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688866
- Sponsor's protocol ID
- 2012.243
- Status last verified
- Oct 2023
- First submitted
- 22 Dec 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04688866
- Acronym / sponsor ID
- 2012.243
- Conditions
- Cervical Insufficiency, Preterm Birth
- Keywords
- preterm birth, cervical insufficiency, cerclage, pessary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hallym University, Health and Medical Research Fund
- Study start
- 5 Jun 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with cervical insufficiency (Cases) | – | Other: SequencingPregnant women with a shortened (<25 mm) or dilated cervix in the second trimester (or late first trimester) |
| Pregnant women without cervical insufficiency (Controls) | – | Other: SequencingPregnant women with a normal-length (>= 25 mm) and closed cervix in the second trimester (or late first trimester) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who attend preterm clinics or receive antenatal care at the participating hospitals.
Key inclusion criteria (1 listed)
- Women with or without cervical insufficiency (cervical length <25 mm or dilated cervix in the second trimester or the late first trimester)
Key exclusion criteria (1 listed)
- multiple pregnancies and pregnancies associated with fetal chromosomal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SequencingThis 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. | Other | Pregnant women with cervical insufficiency (Cases), Pregnant women without cervical insufficiency (Controls) |
Primary outcome
Abundances of microorganisms in the cervix
Time frame: 1 year
Abundances of microorganisms including bacteria and fungi in the cervix are measured by normalized sequencing read counts
3 secondary outcomes
Gestational age at delivery
Time frame: 1 year
Mode of delivery
Time frame: 1 year
Number of participants who received cerclage or ring pessary in the current pregnancy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen S Chim, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Insufficiency and Preterm Birth, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen S Chim, PhD ((852)35051324, sschim@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abundances of microorganisms in the cervix (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.