Trial Outcomes & Findings for Cytomegalovirus Shedding Characteristics in Pregnant Women (NCT NCT04021628)
NCT ID: NCT04021628
Last Updated: 2024-06-07
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
160 participants
Primary outcome timeframe
8 months
Results posted on
2024-06-07
Participant Flow
Participant milestones
| Measure |
All Participants Belonged to the Same Group
All participants belonged to the same group (non-interventional, observational cohort study)
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|---|---|
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Overall Study
STARTED
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160
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Overall Study
COMPLETED
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119
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Overall Study
NOT COMPLETED
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41
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cytomegalovirus Shedding Characteristics in Pregnant Women
Baseline characteristics by cohort
| Measure |
All Participants Belonged to the Same Group
n=160 Participants
All participants belonged to the same group (non-interventional, observational cohort study)
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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160 Participants
n=39 Participants
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Age, Categorical
>=65 years
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0 Participants
n=39 Participants
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Sex: Female, Male
Female
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160 Participants
n=39 Participants
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Sex: Female, Male
Male
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0 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · White British
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69 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · White Other
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39 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · South Asian
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23 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · Asian Other
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9 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · Black
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8 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · Mixed
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11 Participants
n=39 Participants
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Race/Ethnicity, Customized
Ethnicity · Other
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1 Participants
n=39 Participants
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Region of Enrollment
United Kingdom
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160 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: 8 monthsPopulation: The total number of participants with all complete data (no missing data)
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.
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
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Visit 2 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Proportion of Women Approached Who Were Eligible for Screening
n=123 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
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Proportion of Eligible Approached Women Who Had Screening
Pregnant women who were approached and found to be eligible for screening
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Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy
Prevalence in any bodily fluid
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27 Participants
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The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy
Prevalence in saliva
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4 Participants
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The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy
Prevalence in urine
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16 Participants
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The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy
Prevalence in vaginal secretions
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20 Participants
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SECONDARY outcome
Timeframe: 8 monthsThe proportion of detectable CMV virus (measured via polymerase chain reaction) in saliva, urine and vaginal secretions at individual study visits
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=156 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
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Visit 2 Saliva
n=141 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Urine
n=141 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Vaginal Secretions
n=142 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 3 Saliva
n=134 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Urine
n=136 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Vaginal Secretions
n=135 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 4 Urine
n=102 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Visit 4 Vaginal Secretions
n=111 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Proportion of Women Approached Who Were Eligible for Screening
n=155 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
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Proportion of Eligible Approached Women Who Had Screening
n=155 Participants
Pregnant women who were approached and found to be eligible for screening
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Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
n=83 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum
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9 Participants
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3 Participants
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10 Participants
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10 Participants
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3 Participants
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9 Participants
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10 Participants
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0 Participants
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7 Participants
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3 Participants
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9 Participants
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5 Participants
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SECONDARY outcome
Timeframe: 8 monthsPopulation: 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.
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
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=9 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
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Visit 2 Saliva
n=3 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Urine
n=10 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Vaginal Secretions
n=10 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 3 Saliva
n=3 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Urine
n=9 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Vaginal Secretions
n=10 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 4 Urine
n=7 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Visit 4 Vaginal Secretions
n=5 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Proportion of Women Approached Who Were Eligible for Screening
n=3 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
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Proportion of Eligible Approached Women Who Had Screening
n=9 Participants
Pregnant women who were approached and found to be eligible for screening
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Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
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The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum
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800.0 IU/ml
Interval 132.0 to 32000.0
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693.0 IU/ml
Interval 402.0 to 768.0
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104.5 IU/ml
Interval 1.0 to 4930.0
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189.5 IU/ml
Interval 1.0 to 7500.0
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539.0 IU/ml
Interval 137.0 to 634.0
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1.0 IU/ml
Interval 1.0 to 373.0
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640.5 IU/ml
Interval 106.0 to 6480.0
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1.0 IU/ml
Interval 1.0 to 2490.0
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260.0 IU/ml
Interval 166.0 to 639.0
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521.0 IU/ml
Interval 227.0 to 689.0
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1.0 IU/ml
Interval 1.0 to 10900.0
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SECONDARY outcome
Timeframe: 8 monthsThe percentage of women approached who are then recruited into the study
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=804 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
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Visit 2 Saliva
n=384 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Proportion of Women Approached Who Were Eligible for Screening
n=3339 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
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Proportion of Eligible Approached Women Who Had Screening
n=966 Participants
Pregnant women who were approached and found to be eligible for screening
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Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of Pregnant Women Approached Who Are Recruited Into the Study
|
384 Participants
|
160 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
966 Participants
|
804 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 monthsOutcome measures
| Measure |
Visit 1 Vaginal Secretions
n=160 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=160 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
n=160 Participants
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of Participating Pregnant Women Completing the Study
|
119 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
66 Participants
|
123 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Total number of participant who completed the Feedback Questionnaire at Visit 4 (last study visit)
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
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=58 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
n=58 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
n=58 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
n=58 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
n=58 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
n=58 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
n=58 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
n=58 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
n=58 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=58 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
n=58 Participants
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
n=58 Participants
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Acceptability of the Study Procedures to Participating Pregnant Women
|
4.38 Score on a scale
Interval 4.11 to 4.65
|
4.48 Score on a scale
Interval 4.23 to 4.74
|
4.50 Score on a scale
Interval 4.29 to 4.76
|
4.22 Score on a scale
Interval 3.98 to 4.47
|
3.98 Score on a scale
Interval 3.72 to 4.24
|
4.43 Score on a scale
Interval 4.18 to 4.68
|
4.52 Score on a scale
Interval 4.26 to 4.77
|
4.45 Score on a scale
Interval 4.22 to 4.68
|
4.55 Score on a scale
Interval 4.3 to 4.8
|
4.03 Score on a scale
Interval 3.8 to 4.27
|
4.57 Score on a scale
Interval 4.32 to 4.82
|
4.59 Score on a scale
Interval 4.33 to 4.84
|
4.57 Score on a scale
Interval 4.34 to 4.8
|
4.64 Score on a scale
Interval 4.39 to 4.88
|
4.62 Score on a scale
Interval 4.38 to 4.87
|
4.53 Score on a scale
Interval 4.31 to 4.76
|
4.71 Score on a scale
Interval 4.47 to 4.95
|
4.64 Score on a scale
Interval 4.39 to 4.89
|
4.26 Score on a scale
Interval 3.94 to 4.58
|
4.40 Score on a scale
Interval 4.13 to 4.67
|
4.36 Score on a scale
Interval 4.1 to 4.62
|
4.16 Score on a scale
Interval 3.87 to 4.44
|
4.52 Score on a scale
Interval 4.27 to 4.76
|
4.71 Score on a scale
Interval 4.48 to 4.93
|
4.59 Score on a scale
Interval 4.37 to 4.8
|
4.74 Score on a scale
Interval 4.52 to 4.96
|
3.31 Score on a scale
Interval 2.99 to 3.63
|
4.62 Score on a scale
Interval 4.36 to 4.88
|
3.22 Score on a scale
Interval 2.98 to 3.47
|
4.09 Score on a scale
Interval 3.82 to 4.36
|
4.38 Score on a scale
Interval 4.15 to 4.6
|
3.14 Score on a scale
Interval 2.85 to 3.42
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=123 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
Interval 0.6 to 1.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
Total pregnancies (2,3,>3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.36 Odds Ratio
Interval 0.16 to 0.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 0.63 to 11.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
Work regularly with children (yes,no)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.60 Odds Ratio
Interval 0.47 to 5.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
No. of households (<=3,>3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.91 Odds Ratio
Interval 0.2 to 4.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
No. of people per bedroom (1,2,3)
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0.73 Odds Ratio
Interval 0.21 to 2.56
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The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
Age group (<30y,30-39y,>39)
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3.17 Odds Ratio
Interval 0.89 to 11.34
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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)
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0.95 Odds Ratio
Interval 0.62 to 1.47
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The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
Born in UK (Yes, No)
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1.02 Odds Ratio
Interval 0.67 to 3.93
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The Association of Demographics With CMV Shedding in CMV Seropositive Women in Pregnancy
Duration in UK (<5yrs,5-15yrs,>15yrs)
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1.41 Odds Ratio
Interval 0.52 to 3.8
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SECONDARY outcome
Timeframe: 8 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=111 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
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Visit 2 Saliva
n=52 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Proportion of Women Approached Who Were Eligible for Screening
n=152 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
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Proportion of Eligible Approached Women Who Had Screening
n=119 Participants
Pregnant women who were approached and found to be eligible for screening
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Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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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
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0.74 Adjusted Odds Ratio
Interval 0.35 to 1.57
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0.99 Adjusted Odds Ratio
Interval 0.27 to 3.69
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0 Adjusted Odds Ratio
Interval 0.0 to 0.0
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0.74 Adjusted Odds Ratio
Interval 0.4 to 1.4
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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
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1.22 Adjusted Odds Ratio
Interval 0.76 to 1.95
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1.04 Adjusted Odds Ratio
Interval 0.44 to 2.46
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0.81 Adjusted Odds Ratio
Interval 0.45 to 1.46
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1.10 Adjusted Odds Ratio
Interval 0.7 to 1.74
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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
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1.49 Adjusted Odds Ratio
Interval 0.88 to 2.51
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0.54 Adjusted Odds Ratio
Interval 0.2 to 1.45
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1.23 Adjusted Odds Ratio
Interval 0.7 to 2.16
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0.94 Adjusted Odds Ratio
Interval 0.55 to 1.62
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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
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0.47 Adjusted Odds Ratio
Interval 0.26 to 0.85
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0.99 Adjusted Odds Ratio
Interval 0.35 to 2.79
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1.23 Adjusted Odds Ratio
Interval 0.62 to 2.43
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0.90 Adjusted Odds Ratio
Interval 0.51 to 1.56
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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
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1.16 Adjusted Odds Ratio
Interval 0.68 to 1.98
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1.29 Adjusted Odds Ratio
Interval 0.57 to 2.92
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0.72 Adjusted Odds Ratio
Interval 0.41 to 1.28
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0.84 Adjusted Odds Ratio
Interval 0.51 to 1.38
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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
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1.34 Adjusted Odds Ratio
Interval 0.76 to 2.35
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0.69 Adjusted Odds Ratio
Interval 0.25 to 1.91
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1.25 Adjusted Odds Ratio
Interval 0.74 to 2.09
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1.21 Adjusted Odds Ratio
Interval 0.7 to 2.09
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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
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0.54 Adjusted Odds Ratio
Interval 0.26 to 1.12
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2.19 Adjusted Odds Ratio
Interval 0.72 to 6.68
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1.47 Adjusted Odds Ratio
Interval 0.8 to 2.71
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1.58 Adjusted Odds Ratio
Interval 0.9 to 2.78
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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
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0.62 Adjusted Odds Ratio
Interval 0.27 to 1.34
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1.57 Adjusted Odds Ratio
Interval 0.68 to 3.63
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1.08 Adjusted Odds Ratio
Interval 0.6 to 1.92
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0.73 Adjusted Odds Ratio
Interval 0.4 to 1.35
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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
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0.84 Adjusted Odds Ratio
Interval 0.4 to 1.79
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0.31 Adjusted Odds Ratio
Interval 0.07 to 1.43
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1.50 Adjusted Odds Ratio
Interval 0.78 to 2.89
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0.93 Adjusted Odds Ratio
Interval 0.49 to 1.77
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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
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1.17 Adjusted Odds Ratio
Interval 0.66 to 2.09
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0 Adjusted Odds Ratio
Interval 0.0 to 0.0
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1.09 Adjusted Odds Ratio
Interval 0.69 to 1.74
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1.00 Adjusted Odds Ratio
Interval 0.59 to 1.7
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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
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0.77 Adjusted Odds Ratio
Interval 0.42 to 1.42
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2.14 Adjusted Odds Ratio
Interval 0.67 to 6.78
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0.57 Adjusted Odds Ratio
Interval 0.33 to 0.98
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1.16 Adjusted Odds Ratio
Interval 0.69 to 1.98
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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
Interval 0.6 to 1.72
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0.67 Adjusted Odds Ratio
Interval 0.25 to 1.81
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—
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0.64 Adjusted Odds Ratio
Interval 0.36 to 1.12
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1.14 Adjusted Odds Ratio
Interval 0.71 to 1.84
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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
Interval 0.5 to 1.43
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0.70 Adjusted Odds Ratio
Interval 0.28 to 1.77
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—
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—
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—
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—
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—
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—
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—
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0.55 Adjusted Odds Ratio
Interval 0.31 to 0.99
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0.78 Adjusted Odds Ratio
Interval 0.46 to 1.31
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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
Interval 0.73 to 2.08
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1.06 Adjusted Odds Ratio
Interval 0.53 to 2.1
|
—
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—
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—
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—
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—
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—
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—
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0.87 Adjusted Odds Ratio
Interval 0.55 to 1.37
|
1.22 Adjusted Odds Ratio
Interval 0.77 to 1.93
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 8 monthsPopulation: Not all participant recruited in the study were tested with CMV -QuantiFERON assay.
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
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=88 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women in Pregnancy
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 8 monthsThe 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
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=67 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Prevalence of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women in Pregnancy
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
67 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
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—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: 8 monthsThe 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
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=42 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
n=16 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=72 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
n=52 Participants
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-QuantiFERON in CMV Seropositive Women Throughout Pregnancy and Postpartum
|
31 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
50 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 monthsThe 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
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=26 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
n=8 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=49 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
n=25 Participants
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of CMV-specific T-cell Immune Responses as Measured by CMV-ELISPOT in CMV Seropositive Women Throughout Pregnancy and Postpartum
|
25 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
49 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=42 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
|
Visit 2 Saliva
n=12 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 2 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
|
Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
|
Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
|
Proportion of Women Approached Who Were Eligible for Screening
n=72 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
|
Proportion of Eligible Approached Women Who Had Screening
n=51 Participants
Pregnant women who were approached and found to be eligible for screening
|
Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
|
Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-QuantiFERON
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2.82 Odds Ratio
Interval 0.26 to 30.66
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0.00 Odds Ratio
Interval 0.0 to 0.0
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—
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—
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—
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—
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—
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0.56 Odds Ratio
Interval 0.11 to 2.76
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1.19 Odds Ratio
Interval 0.21 to 6.68
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SECONDARY outcome
Timeframe: 8 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Visit 1 Vaginal Secretions
n=24 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 1 (up to 16 weeks and 6 days gestational age)
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Visit 2 Saliva
n=24 Participants
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Urine
n=26 Participants
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 2 Vaginal Secretions
n=26 Participants
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 2 (from 17 weeks and 0 days gestational age to 27 weeks and 6 days gestational age)
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Visit 3 Saliva
Saliva sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 3 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 3 (from 28 weeks and 0 days gestational age onwards)
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Visit 4 Urine
Urine sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Visit 4 Vaginal Secretions
Vaginal secretions sample (one per participant) tested for CMV DNA via PCR at Visit 4 (anytime from the time of birth to 1 week postnatal age)
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Proportion of Women Approached Who Were Eligible for Screening
n=49 Participants
Pregnant women who were approached at early antenatal appointment and were found to be eligible for screening
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Proportion of Eligible Approached Women Who Had Screening
n=49 Participants
Pregnant women who were approached and found to be eligible for screening
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Happy to Ask Questions at Recruitment Visit (Visit 1) Which Were Appropriately Addressed
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Satisfied With Information Received at Recruitment Visit (Visit 1) and Understood Next Steps
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Background Questionnaire
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Complete the Contact Questionnaire at All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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The Self-sampling Written Instructions Were Simple and Clear
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Saliva Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Urine Samples for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform Self-sampling of Vaginal Secretions for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Perform All Self-sampling for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Blood Samples Taken for All Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Additional Blood Samples Taken on Top of Routine Antenatal Blood Samples
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Have the Option to Test Newborn for Congenital CMV
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to be Part of All Four Study Visits
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Study Visit Timeline Was Not Troublesome
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Happy to Receive Study Visit Text Reminders
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Attend Study Visits That do Not Coincide With Routine Antenatal Appoinments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at the Same Time as Routine Antenatal Appointments
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Prefer to Have Study Visits at Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Contact Study Team When in Labour or Soon After Birth
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit Soon After Birth Whilst Still in Hospital
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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Willing to Have Study Visit With Newborn in Hospital/Clinic After Already Being Discharged Home
Feedback statement from the Feedback Questionnaire. Score between 1 to 5, where higher score indicated higher agreement to the feedback statement.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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The Association Between CMV-specific T Cell Immune Response and CMV Shedding in CMV Seropositive Pregnant Women as Measured by CMV-ELISPOT
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1.00 Odds Ratio
Interval 0.99 to 1.0
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0.97 Odds Ratio
Interval 0.94 to 0.99
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1.00 Odds Ratio
Interval 0.98 to 1.01
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0.99 Odds Ratio
Interval 0.98 to 1.01
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—
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1.00 Odds Ratio
Interval 0.99 to 1.01
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0.99 Odds Ratio
Interval 0.98 to 1.0
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Adverse Events
All Participants Belonged to the Same Group
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants Belonged to the Same Group
n=160 participants at risk
All participants belonged to the same group (non-interventional, observational cohort study)
|
|---|---|
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Reproductive system and breast disorders
Postpartum haemorrhage requiring blood transfusion
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2.5%
4/160 • Number of events 4 • 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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Reproductive system and breast disorders
Admission of newborn to neonatal unit
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4.4%
7/160 • Number of events 7 • 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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Other adverse events
| Measure |
All Participants Belonged to the Same Group
n=160 participants at risk
All participants belonged to the same group (non-interventional, observational cohort study)
|
|---|---|
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Reproductive system and breast disorders
Emergency caesarian section
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0.62%
1/160 • Number of events 1 • 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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Reproductive system and breast disorders
Gestational diabetes
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4.4%
7/160 • Number of events 7 • 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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Gastrointestinal disorders
Gastroenteritis
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0.62%
1/160 • Number of events 1 • 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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Infections and infestations
Upper respiratory tract infection
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0.62%
1/160 • Number of events 1 • 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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Reproductive system and breast disorders
Induction of labour for IUGR
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0.62%
1/160 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place