CMV, Congenital Cmv, Maternal Infections Affecting Fetus or Newborn, Shedding Virus
Conditions
Keywords
cmv, cytomegalovirus, shedding, excretion, congenital, cCMV, seropositive, maternal
Brief 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 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.
Interventions
OTHERNo intervention- not applicable
No intervention - not applicable
Sponsors
St George's University Hospitals NHS Foundation Trust
St George's, University of London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 8 months | 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 |
| The Proportion of Pregnant Women Approached Who Are Recruited Into the Study | 8 months | The percentage of women approached who are then recruited into the study |
| The Proportion of Participating Pregnant Women Completing the Study | 8 months | — |
| The Acceptability of the Study Procedures to Participating Pregnant Women | 8 months | 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 |
| The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | 8 months | 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. |
| The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | 8 months | 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 Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 8 months | The proportion of detectable CMV virus (measured via polymerase chain reaction) in saliva, urine and vaginal secretions at individual study visits |
| The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women in Pregnancy | 8 months | 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 |
| The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum | 8 months | 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 |
| The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum | 8 months | 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 |
| The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON | 8 months | 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 Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 8 months | 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 Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women in Pregnancy | 8 months | 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 |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Belonged to the Same Group All participants belonged to the same group (non-interventional, observational cohort study) | 160 |
| Total | 160 |
Baseline characteristics
| Characteristic | All Participants Belonged to the Same Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 160 Participants |
| Race/Ethnicity, Customized Ethnicity Asian Other | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 8 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 1 Participants |
| Race/Ethnicity, Customized Ethnicity South Asian | 23 Participants |
| Race/Ethnicity, Customized Ethnicity White British | 69 Participants |
| Race/Ethnicity, Customized Ethnicity White Other | 39 Participants |
| Region of Enrollment United Kingdom | 160 Participants |
| Sex: Female, Male Female | 160 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 160 |
| other Total, other adverse events | 11 / 160 |
| serious Total, serious adverse events | 11 / 160 |
Outcome results
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.
Time frame: 8 months
Population: The total number of participants with all complete data (no missing data)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants Belonged to the Same Group | The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy | Prevalence in any bodily fluid | 27 Participants |
| All Participants Belonged to the Same Group | The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy | Prevalence in saliva | 4 Participants |
| All Participants Belonged to the Same Group | The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy | Prevalence in urine | 16 Participants |
| All Participants Belonged to the Same Group | The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy | Prevalence in vaginal secretions | 20 Participants |
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
Time frame: 8 months
Population: Total number of participant who completed the Feedback Questionnaire at Visit 4 (last study visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants Belonged to the Same Group | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.03 Score on a scale |
| Visit 1 Urine | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.57 Score on a scale |
| Visit 1 Vaginal Secretions | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.38 Score on a scale |
| Visit 2 Saliva | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.48 Score on a scale |
| Visit 2 Urine | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.50 Score on a scale |
| Visit 2 Vaginal Secretions | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.22 Score on a scale |
| Visit 3 Saliva | The Acceptability of the Study Procedures to Participating Pregnant Women | 3.98 Score on a scale |
| Visit 3 Urine | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.43 Score on a scale |
| Visit 3 Vaginal Secretions | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.52 Score on a scale |
| Visit 4 Saliva | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.45 Score on a scale |
| Visit 4 Urine | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.55 Score on a scale |
| Visit 4 Vaginal Secretions | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.59 Score on a scale |
| Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.57 Score on a scale |
| Willing to Complete the Background Questionnaire | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.64 Score on a scale |
| Willing to Complete the Contact Questionnaire at All Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.62 Score on a scale |
| The Self-sampling Written Instructions Were Simple and Clear | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.53 Score on a scale |
| Willing to Perform Self-sampling of Saliva Samples for All Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.71 Score on a scale |
| Willing to Perform Self-sampling of Urine Samples for All Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.64 Score on a scale |
| Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.26 Score on a scale |
| Willing to Perform All Self-sampling for All Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.40 Score on a scale |
| Willing to Have Blood Samples Taken for All Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.36 Score on a scale |
| Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.16 Score on a scale |
| Happy to Have the Option to Test Newborn for Congenital CMV | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.52 Score on a scale |
| Willing to be Part of All Four Study Visits | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.71 Score on a scale |
| Study Visit Timeline Was Not Troublesome | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.59 Score on a scale |
| Happy to Receive Study Visit Text Reminders | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.74 Score on a scale |
| Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments | The Acceptability of the Study Procedures to Participating Pregnant Women | 3.31 Score on a scale |
| Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.62 Score on a scale |
| Prefer to Have Study Visits at Home | The Acceptability of the Study Procedures to Participating Pregnant Women | 3.22 Score on a scale |
| Willing to Contact Study Team When in Labour or Soon After Birth | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.09 Score on a scale |
| Willing to Have Study Visit Soon After Birth Whilst Still in Hospital | The Acceptability of the Study Procedures to Participating Pregnant Women | 4.38 Score on a scale |
| Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home | The Acceptability of the Study Procedures to Participating Pregnant Women | 3.14 Score on a scale |
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.
Time frame: 8 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Belonged to the Same Group | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 1.00 Odds Ratio |
| Visit 1 Urine | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 0.99 Odds Ratio |
| Visit 1 Vaginal Secretions | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 1.00 Odds Ratio |
| Visit 2 Saliva | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 0.97 Odds Ratio |
| Visit 2 Urine | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 1.00 Odds Ratio |
| Visit 2 Vaginal Secretions | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT | 0.99 Odds Ratio |
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.
Time frame: 8 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Belonged to the Same Group | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON | 0.56 Odds Ratio |
| Visit 1 Urine | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON | 1.19 Odds Ratio |
| Visit 1 Vaginal Secretions | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON | 2.82 Odds Ratio |
| Visit 2 Saliva | The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON | 0.00 Odds Ratio |
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.
Time frame: 8 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after wiping child's nose | 1.50 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after wiping child's nose | 1.08 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling with child's urine | 0.72 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Kiss child on the lips | 0.87 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after wiping child's nose | 1.47 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling with child's urine | 1.25 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat with child's used cutlery | 0.64 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling child's faeces | 0 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling child's faeces | 1.23 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Drink from child's used cup | 0.55 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat child's leftover food | 0.57 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Put child's dummy in own mouth | 1.09 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling with child's urine | 1.23 Adjusted Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling child's faeces | 0.81 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat child's leftover food | 1.16 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling child's faeces | 0.74 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling child's faeces | 1.10 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling child's faeces | 0.94 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling with child's urine | 0.90 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling with child's urine | 0.84 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling with child's urine | 1.21 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after wiping child's nose | 1.58 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after wiping child's nose | 0.73 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after wiping child's nose | 0.93 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Put child's dummy in own mouth | 1.00 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat with child's used cutlery | 1.14 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Drink from child's used cup | 0.78 Adjusted Odds Ratio |
| Visit 1 Urine | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Kiss child on the lips | 1.22 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat child's leftover food | 0.77 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Drink from child's used cup | 0.84 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling child's faeces | 1.22 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling with child's urine | 0.47 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat with child's used cutlery | 1.01 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling child's faeces | 0.74 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Put child's dummy in own mouth | 1.17 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after wiping child's nose | 0.62 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling with child's urine | 1.34 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling child's faeces | 1.49 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling with child's urine | 1.16 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Kiss child on the lips | 1.23 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after wiping child's nose | 0.54 Adjusted Odds Ratio |
| Visit 1 Vaginal Secretions | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after wiping child's nose | 0.84 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after wiping child's nose | 2.19 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after wiping child's nose | 1.57 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Drink from child's used cup | 0.70 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after wiping child's nose | 0.31 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling child's faeces | 0.54 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Put child's dummy in own mouth | 0 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling child's faeces | 1.04 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat child's leftover food | 2.14 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Kiss child on the lips | 1.06 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Eat with child's used cutlery | 0.67 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands without soap after handling with child's urine | 1.29 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling child's faeces | 0.99 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Clean hands with alcohol gel after handling with child's urine | 0.69 Adjusted Odds Ratio |
| Visit 2 Saliva | The Association of Contact With Young Children's Bodily Fluids With CMV Shedding in CMV Seropositive Women Throughout Pregnancy and Postpartum | Wash hands with soap after handling with child's urine | 0.99 Adjusted Odds Ratio |
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.
Time frame: 8 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Work regularly with children (yes,no) | 1.60 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Age group (<30y,30-39y,>39) | 3.17 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Ethnicity (White(W)British,WOther(O),SouthAsian(A),AO,Black,Mixed,O) | 0.95 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Born in UK (Yes, No) | 1.02 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Duration in UK (<5yrs,5-15yrs,>15yrs) | 1.41 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Highest Education (PhD/Masters, Degree, Diploma, ALevels/GCSE) | 0.99 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | Total pregnancies (2,3,>3) | 0.36 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | No. of children (1,2,>2): OR 2.0 [95% CI 0.3,12.3], p=0.445 | 2.73 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | No. of households (<=3,>3) | 0.91 Odds Ratio |
| All Participants Belonged to the Same Group | The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy | No. of people per bedroom (1,2,3) | 0.73 Odds Ratio |
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
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women in Pregnancy | 67 Participants |
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
Time frame: 8 months
Population: Not all participant recruited in the study were tested with CMV -QuantiFERON assay.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women in Pregnancy | 62 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
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 3 Participants |
| Visit 1 Urine | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 9 Participants |
| Visit 1 Vaginal Secretions | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 9 Participants |
| Visit 2 Saliva | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 3 Participants |
| Visit 2 Urine | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 10 Participants |
| Visit 2 Vaginal Secretions | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 10 Participants |
| Visit 3 Saliva | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 3 Participants |
| Visit 3 Urine | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 9 Participants |
| Visit 3 Vaginal Secretions | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 10 Participants |
| Visit 4 Saliva | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 0 Participants |
| Visit 4 Urine | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 7 Participants |
| Visit 4 Vaginal Secretions | The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum | 5 Participants |
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
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum | 49 Participants |
| Visit 1 Urine | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum | 24 Participants |
| Visit 1 Vaginal Secretions | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum | 25 Participants |
| Visit 2 Saliva | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum | 8 Participants |
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
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum | 50 Participants |
| Visit 1 Urine | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum | 39 Participants |
| Visit 1 Vaginal Secretions | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum | 31 Participants |
| Visit 2 Saliva | The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum | 10 Participants |
Secondary
The Proportion of Participating Pregnant Women Completing the Study
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Proportion of Participating Pregnant Women Completing the Study | 66 Participants |
| Visit 1 Urine | The Proportion of Participating Pregnant Women Completing the Study | 123 Participants |
| Visit 1 Vaginal Secretions | The Proportion of Participating Pregnant Women Completing the Study | 119 Participants |
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
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Belonged to the Same Group | The Proportion of Pregnant Women Approached Who Are Recruited Into the Study | 966 Participants |
| Visit 1 Urine | The Proportion of Pregnant Women Approached Who Are Recruited Into the Study | 804 Participants |
| Visit 1 Vaginal Secretions | The Proportion of Pregnant Women Approached Who Are Recruited Into the Study | 384 Participants |
| Visit 2 Saliva | The Proportion of Pregnant Women Approached Who Are Recruited Into the Study | 160 Participants |
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
Time frame: 8 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants Belonged to the Same Group | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 521.0 IU/ml |
| Visit 1 Urine | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 1.0 IU/ml |
| Visit 1 Vaginal Secretions | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 800.0 IU/ml |
| Visit 2 Saliva | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 693.0 IU/ml |
| Visit 2 Urine | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 104.5 IU/ml |
| Visit 2 Vaginal Secretions | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 189.5 IU/ml |
| Visit 3 Saliva | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 539.0 IU/ml |
| Visit 3 Urine | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 1.0 IU/ml |
| Visit 3 Vaginal Secretions | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 640.5 IU/ml |
| Visit 4 Saliva | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 1.0 IU/ml |
| Visit 4 Urine | The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum | 260.0 IU/ml |