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| Name | Class |
|---|---|
| St George's University Hospitals NHS Foundation Trust | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention- not applicable | Other | No intervention - not applicable |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 months |
| The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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CMV seropositive pregnant women with at least one child of less than four years of age
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| Name | Affiliation | Role |
|---|---|---|
| Shari Sapuan | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George's University Hospitals NHS Foundation Trust | London | SW170RE | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Belonged to the Same Group | All participants belonged to the same group (non-interventional, observational cohort study) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Belonged to the Same Group | All participants belonged to the same group (non-interventional, observational cohort study) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The total number of participants with all complete data (no missing data) | Posted | Count of Participants | Participants | 8 months |
|
8 months
The definitions and assessment of adverse event and serious adverse event are in accordance with the Health Research Authority, England, United Kingdom
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants Belonged to the Same Group | All participants belonged to the same group (non-interventional, observational cohort study) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postpartum haemorrhage requiring blood transfusion | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency caesarian section | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shari Sapuan | St George's, University of London | 02086729944 | 5382 | ssapuan@sgul.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2020 | Mar 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Samples with DNA of CMV virus, not human DNA
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 |
| 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 | 8 months |
| The Proportion of Participating Pregnant Women Completing the Study | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 8 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | 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 | As there was no CMV DNA via PCR detected from the participants' saliva samples tested at Visit 4, this arm was excluded from the statistical analysis. Where CMV DNA was detected below the assay's limit of quantification, the quantity was defined as 1.0 IU/ml for the purpose of statistical analysis. | Posted | Median | Full Range | IU/ml | 8 months |
|
|
|
| Secondary | The Proportion of Pregnant Women Approached Who Are Recruited Into the Study | The percentage of women approached who are then recruited into the study | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | The Proportion of Participating Pregnant Women Completing the Study | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | 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 | Total number of participant who completed the Feedback Questionnaire at Visit 4 (last study visit) | Posted | Mean | 95% Confidence Interval | Score on a scale | 8 months |
|
|
|
| Secondary | 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. | Multiple logistic regression with CMV shedding in pregnancy status (detected or not detected) as the dependent variable (outcome) and the demographic variables as the independent variables (predictors), on participants where all saliva, urine and vaginal secretion samples were collected and tested at Visit 1, Visit 2 and Visit 3. | Posted | Number | 95% Confidence Interval | Odds Ratio | 8 months |
|
|
|
| Secondary | 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. | 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 adjusted logistic regression. | Posted | Number | 95% Confidence Interval | Adjusted Odds Ratio | 8 months |
|
|
|
| Secondary | 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 | Not all participant recruited in the study were tested with CMV -QuantiFERON assay. | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | 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. | 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, in CMV seropositive women. | Posted | Number | 95% Confidence Interval | Odds Ratio | 8 months |
|
|
|
| Secondary | 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. | 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, in CMV seropositive women. | Posted | Number | 95% Confidence Interval | Odds Ratio | 8 months |
|
|
|
| 0 |
| 160 |
| 11 |
| 160 |
| 11 |
| 160 |
| Admission of newborn to neonatal unit | Reproductive system and breast disorders | Systematic Assessment |
|
| Gestational diabetes | Reproductive system and breast disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Induction of labour for IUGR | Reproductive system and breast disorders | Systematic Assessment |
|
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| Duration in UK (<5yrs,5-15yrs,>15yrs) |
|
| Highest Education (PhD/Masters, Degree, Diploma, ALevels/GCSE) |
|
| Total pregnancies (2,3,>3) |
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| No. of children (1,2,>2): OR 2.0 [95% CI 0.3,12.3], p=0.445 |
|
| Work regularly with children (yes,no) |
|
| No. of households (<=3,>3) |
|
| No. of people per bedroom (1,2,3) |
|
| Wash hands without soap after handling child's faeces |
|
| Clean hands with alcohol gel after handling child's faeces |
|
| Wash hands with soap after handling with child's urine |
|
| Wash hands without soap after handling with child's urine |
|
| Clean hands with alcohol gel after handling with child's urine |
|
| Wash hands with soap after wiping child's nose |
|
| Wash hands without soap after wiping child's nose |
|
| Clean hands with alcohol gel after wiping child's nose |
|
| Put child's dummy in own mouth |
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| Eat child's leftover food |
|
| Eat with child's used cutlery |
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| Drink from child's used cup |
|
| Kiss child on the lips |
|