CMVcCHIPSNCT04021628
Cytomegalovirus Shedding Characteristics in Pregnant Women
An observational study of CMV and Congenital Cmv, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
The cCHIPS study is a feasibility study for larger scale multi-centre studies and is designed as a single-centre observational cohort, longitudinal, natural history study. The overarching aim of this study is to evaluate the feasibility of performing larger scale, multi-centre studies to evaluate the relationship… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- CMV, Congenital Cmv, Maternal Infections Affecting Fetus or Newborn
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Adult, Older adult
Study population: CMV seropositive pregnant women with at least one child of less than four years of age
Who may be able to join
- Pregnant
- CMV seropositive
- Willing and able to provide informed consent
- Living with child(ren), at least one of whom is less than four years old
- Willing to have saliva, urine and vaginal secretion sampling to be tested for CMV PCR
- Willing to be followed up until the postpartum period
Who cannot join
- Age less than 18 years
- Evidence of acute maternal CMV infection at the time of screening
- Documented immunodeficiency of any aetiology including the use of oral steroid therapy equivalent to >1mg/kg of prednisone per day for more than one week
- In the opinion of the investigator is unlikely to comply with the study procedures
- In the opinion of the investigator does not have adequate understanding or verbal and written English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's University Hospitals NHS Foundation Trust
London, SW170RE
About this study
Official title: An Observational, Longitudinal, Natural History, Feasibility Cohort Study to Evaluate the Characteristics of Cytomegalovirus (CMV) Shedding in CMV Seropositive Women Throughout Pregnancy
The cCHIPS study is a feasibility study for larger scale multi-centre studies and is designed as a single-centre observational cohort, longitudinal, natural history study.
The overarching aim of this study is to evaluate the feasibility of performing larger scale, multi-centre studies to evaluate the relationship between CMV shedding in pregnancy with congenital CMV (cCMV). There is no randomisation involved in this study and all participants will perform the same study procedures and receive treatment as usual.
Read more
The primary (main) objective is to evaluate the prevalence (percentage of occurrence) of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy.
The secondary objectives are to evaluate the quantity of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy, to compare the prevalence and quantity of CMV shedding in CMV seropositive women between different sources of shedding (saliva, urine or vaginal secretions) and different gestational stages, to identify risk factors for CMV shedding in CMV seropositive pregnant women, to evaluate the acceptability of the study procedures to the participating pregnant women, to evaluate the proportion of women approached who are recruited into the study and who are completing the study, and to evaluate the relationship between CMV specific cell mediated immunity (a type of immune protection following exposure to CMV) and CMV shedding in CMV seropositive pregnant women.
The tertiary objective is to compare the evaluation of CMV specific T cell immune responses (a type of CMV specific cell mediated immunity) between the two commercially available CMV-specific T cell immune response assays which are QuantiFERON-CMV and CMV-ELISPOT assays.
This study will aim to recruit 200 pregnant women.
This study will be undertaken in parallel with a separate study called RACE-FIT (REC reference number 18/SC/0360, IRAS ID 239977), which will have ethical approval to screen pregnant women with children less than 4 years of age booked for their antenatal care at St George's Hospital, London, identified during the antenatal combined screening bloods appointment or the antenatal booking appointment, for their CMV serology status on a sample of blood collected as part of the screening process. As part of the ethical approval sought for the RACE-FIT study and the cCHIPS study, the pregnant women screened and found to be CMV seronegative will be eligible for recruitment into the RACE-FIT study and those screened and found to be CMV seropositive will be eligible and approached for recruitment into the cCHIPS study.
The cCHIPS study aim to recruit over a 6 month period.
The study involves four visits (Visit 1, Visit 2, Visit 3, Visit 4) for each participant. The total study period for each participant will be between 6 to 8 months.
Read the detailed description
The potential participants will be contacted via telephone, email and/or post by the study team. They will be screened for their eligibility, and if they are interested in participating, the first study visit (Visit 1) will be arranged where the written informed consent will be obtained then before any study related procedures.
Visit 1 will be held as soon as possible following screening, aiming up to 16 weeks and 6 days gestational age (early in pregnancy). Visit 2 will be aimed to coincide with the routine 20 gestational week appointment or any time in second trimester from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age (middle of pregnancy). Visit 3 will be aimed to coincide with the routine 28 gestational week appointment or any time in the third trimester from 28 weeks and 0 days gestational age onwards (late in pregnancy), Visit 4 will be aimed to coincide with the participant's routine admission on the labour ward or postnatal ward after giving birth, or anytime from the time of birth to 1 week postnatal age (postpartum period).
At each study visit, the participants will be performing their own study samples of saliva, urine and vaginal secretions using the study specific self-sampling instructions provided. These self-samples will be tested for the presence and quantity of CMV DNA detected via a molecular technique called polymerase chain reaction (PCR). If consent is obtained, a blood sample will also be collected at each study visit to test for cellular mediated immunity. At the last visit, the participant will be offered to have her newborn baby tested for congenital CMV by collecting the newborn's saliva sample which will be tested for CMV DNA via PCR.
At each study visit, the participant will complete a short questionnaire on the participant's contact with their child(ren)'s saliva and urine (to identify risk factors for CMV shedding). At Visit 1, the participant will complete a background questionnaire (also to identify risk factors for CMV shedding)and at Visit 4 a feedback questionnaire (to assess feasibility).
Where possible the study visits and blood samples will be aimed to take place alongside the participants' routine antenatal appointments and routine blood tests respectively.
At the end of the study, up to 20 participants will be invited to take part in a process evaluation in the form of an interview by phone, skype or face to face to explore in depth the experiences of participation in the study.
- Being tested
- No intervention- not applicable
- Keywords
- cmv, cytomegalovirus, shedding, excretion, congenital, cCMV, seropositive, maternal
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention- not applicableOther
No intervention - not applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy
The percentage of participants with detectable CMV virus (detected via polymerase chain reaction) in any bodily fluid (saliva, urine or vaginal secretions) at any point in pregnancy, and the percentage of participants with detectable CMV virus in each bodily fluid (saliva, urine and vaginal secretions) at any point in pregnancy.
Measured: 8 months
Secondary outcomes (13)
The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum
The proportion of detectable CMV virus (measured via polymerase chain reaction) in saliva, urine and vaginal secretions at individual study visits
Measured: 8 months
The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum
The quantity of detectable CMV virus (measured via quantitative polymerase chain reaction in IU/ml) in saliva, urine and vaginal secretions at individual study visits
Measured: 8 months
The Proportion of Pregnant Women Approached Who Are Recruited Into the Study
The percentage of women approached who are then recruited into the study
Measured: 8 months
The Proportion of Participating Pregnant Women Completing the Study
Measured: 8 months
The Acceptability of the Study Procedures to Participating Pregnant Women
Descriptive summary of the mean scores of each feedback statement (scale 1 to 5, where higher score was indicative of higher agreement to the feedback statement) from the Feedback Questionnaire completed by participants at the last study visit
Measured: 8 months
The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
The multiple logistic regression of CMV shedding as an outcome (dependent variable; detected or not detected) at any visit during pregnancy with demographic factors (independent variable) as a predictor, adjusted for all demographic variables described, using odds ratio in the results between CMV seropositive women with CMV shedding and without CMV shedding, with 95% confidence interval.
Measured: 8 months
The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum
The association between CMV shedding detection and the specific types of contact with child(ren)'s bodily fluids as assessed in the contact questionnaire at each visit, performed using logistic regression (CMV shedding detection as the outcome variable, the specific types of contact with children's bodily fluids as the predictor varible), adjusted for age, ethnicity, education, and amount of children, with the detection of shedding as a binary outcome, using odds ratio in the results between CMV-seropositive with CMV shedding and without CMV shedding, with 95% confidence intervals.
Measured: 8 months
The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women in Pregnancy
The percentage of the number of participants with positive CMV-QuantiFERON results over the total number of participants tested with CMV-QuantiFERON at any point in pregnancy
Measured: 8 months
The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women in Pregnancy
The percentage of the number of participants with responsive CMV-ELISPOT results over the total number of participants tested with CMV-ELISPOT at any point in pregnancy
Measured: 8 months
The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum
The percentage of the number of participants with positive CMV-QuantiFERON results over the total number of participants tested for CMV-QuantiFERON at each study visit
Measured: 8 months
The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum
The percentage of the number of participants with responsive CMV-ELISPOT results (a positive spot count to IE-1 and/or pp65 antigen) over the total number of participants tested for CMV-ELISPOT at each study visit
Measured: 8 months
The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON
The logistic regression of CMV shedding as an outcome (dependent variable; detected or not detected) at a visit with CMV-QuantiFERON assay results (independent variable; positive or negative) as a predictor at the reciprocal visit, adjusted for age and ethnicity, using odds ratio in the results between CMV seropositive women with CMV shedding and without CMV shedding, with 95% confidence interval.
Measured: 8 months
The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT
The logistic regression of CMV shedding as an outcome (dependent variable; detected or not detected) at a visit with CMV-ELISPOT assay results (independent variable; spot count) as a predictor at the reciprocal visit, adjusted for age and ethnicity, using odds ratio in the results between CMV seropositive women with CMV shedding and without CMV shedding, with 95% confidence interval.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Apr 2019
- Primary completion1 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CMVStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Shari Sapuan, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021628
- Sponsor's protocol ID
- 2018.0296
- Acronym
- cCHIPS
- Status last verified
- Dec 2023
- First submitted
- 1 Jul 2019
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Longitudinal, Natural History, Feasibility Cohort Study to Evaluate the Characteristics of Cytomegalovirus (CMV) Shedding in CMV Seropositive Women Throughout Pregnancy
- ClinicalTrials.gov ID
- NCT04021628
- Acronym / sponsor ID
- cCHIPS / 2018.0296
- Keywords
- cmv, cytomegalovirus, shedding, excretion, congenital, cCMV, seropositive, maternal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cCHIPS study is a feasibility study for larger scale multi-centre studies and is designed as a single-centre observational cohort, longitudinal, natural history study.
The overarching aim of this study is to evaluate the feasibility of performing larger scale, multi-centre studies to evaluate the relationship between CMV shedding in pregnancy with congenital CMV (cCMV). There is no randomisation involved in this study and all participants will perform the same study procedures and receive treatment as usual.
The primary (main) objective is to evaluate the prevalence (percentage of occurrence) of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy.
The secondary objectives are to evaluate the quantity of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy, to compare the prevalence and quantity of CMV shedding in CMV seropositive women between different sources of shedding (saliva, urine or vaginal secretions) and different gestational stages, to identify risk factors for CMV shedding in CMV seropositive pregnant women, to evaluate the acceptability of the study procedures to the participating pregnant women, to evaluate the proportion of women approached who are recruited into the study and who are completing the study, and to evaluate the relationship between CMV specific cell mediated immunity (a type of immune protection following exposure to CMV) and CMV shedding in CMV seropositive pregnant women.
The tertiary objective is to compare the evaluation of CMV specific T cell immune responses (a type of CMV specific cell mediated immunity) between the two commercially available CMV-specific T cell immune response assays which are QuantiFERON-CMV and CMV-ELISPOT assays.
This study will aim to recruit 200 pregnant women.
This study will be undertaken in parallel with a separate study called RACE-FIT (REC reference number 18/SC/0360, IRAS ID 239977), which will have ethical approval to screen pregnant women with children less than 4 years of age booked for their antenatal care at St George's Hospital, London, identified during the antenatal combined screening bloods appointment or the antenatal booking appointment, for their CMV serology status on a sample of blood collected as part of the screening process. As part of the ethical approval sought for the RACE-FIT study and the cCHIPS study, the pregnant women screened and found to be CMV seronegative will be eligible for recruitment into the RACE-FIT study and those screened and found to be CMV seropositive will be eligible and approached for recruitment into the cCHIPS study.
The cCHIPS study aim to recruit over a 6 month period.
The study involves four visits (Visit 1, Visit 2, Visit 3, Visit 4) for each participant. The total study period for each participant will be between 6 to 8 months.
Detailed description
The potential participants will be contacted via telephone, email and/or post by the study team. They will be screened for their eligibility, and if they are interested in participating, the first study visit (Visit 1) will be arranged where the written informed consent will be obtained then before any study related procedures.
Visit 1 will be held as soon as possible following screening, aiming up to 16 weeks and 6 days gestational age (early in pregnancy). Visit 2 will be aimed to coincide with the routine 20 gestational week appointment or any time in second trimester from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age (middle of pregnancy). Visit 3 will be aimed to coincide with the routine 28 gestational week appointment or any time in the third trimester from 28 weeks and 0 days gestational age onwards (late in pregnancy), Visit 4 will be aimed to coincide with the participant's routine admission on the labour ward or postnatal ward after giving birth, or anytime from the time of birth to 1 week postnatal age (postpartum period).
At each study visit, the participants will be performing their own study samples of saliva, urine and vaginal secretions using the study specific self-sampling instructions provided. These self-samples will be tested for the presence and quantity of CMV DNA detected via a molecular technique called polymerase chain reaction (PCR). If consent is obtained, a blood sample will also be collected at each study visit to test for cellular mediated immunity. At the last visit, the participant will be offered to have her newborn baby tested for congenital CMV by collecting the newborn's saliva sample which will be tested for CMV DNA via PCR.
At each study visit, the participant will complete a short questionnaire on the participant's contact with their child(ren)'s saliva and urine (to identify risk factors for CMV shedding). At Visit 1, the participant will complete a background questionnaire (also to identify risk factors for CMV shedding)and at Visit 4 a feedback questionnaire (to assess feasibility).
Where possible the study visits and blood samples will be aimed to take place alongside the participants' routine antenatal appointments and routine blood tests respectively.
At the end of the study, up to 20 participants will be invited to take part in a process evaluation in the form of an interview by phone, skype or face to face to explore in depth the experiences of participation in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- CMV seropositive pregnant women with at least one child of less than four years of age
Key inclusion criteria (6 listed)
- Pregnant
- CMV seropositive
- Willing and able to provide informed consent
- Living with child(ren), at least one of whom is less than four years old
- Willing to have saliva, urine and vaginal secretion sampling to be tested for CMV PCR
Key exclusion criteria (5 listed)
- Age less than 18 years
- Evidence of acute maternal CMV infection at the time of screening
- Documented immunodeficiency of any aetiology including the use of oral steroid therapy equivalent to >1mg/kg of prednisone per day for more than one week
- In the opinion of the investigator is unlikely to comply with the study procedures
- In the opinion of the investigator does not have adequate understanding or verbal and written English
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 |
|---|---|---|
| No intervention- not applicableNo intervention - not applicable | Other | – |
Primary outcome
The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy
Time frame: 8 months
The percentage of participants with detectable CMV virus (detected via polymerase chain reaction) in any bodily fluid (saliva, urine or vaginal secretions) at any point in pregnancy, and the percentage of participants with detectable CMV virus in each bodily fluid (saliva, urine and vaginal secretions) at any point in pregnancy.
13 secondary outcomes
The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum
Time frame: 8 months
The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum
Time frame: 8 months
The Proportion of Pregnant Women Approached Who Are Recruited Into the Study
Time frame: 8 months
The Proportion of Participating Pregnant Women Completing the Study
Time frame: 8 months
The Acceptability of the Study Procedures to Participating Pregnant Women
Time frame: 8 months
The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
Time frame: 8 months
The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum
Time frame: 8 months
The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women in Pregnancy
Time frame: 8 months
The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women in Pregnancy
Time frame: 8 months
The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum
Time frame: 8 months
The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum
Time frame: 8 months
The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON
Time frame: 8 months
The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shari Sapuan principal investigator
St George's, University of London
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 CMV and Congenital Cmv, run by St George's, University of London at 1 site in United Kingdom.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jun 2024. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy (time frame: 8 months). 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 7 Jun 2024.