Cytomegalovirus Shedding Characteristics in Pregnant Women

NCT04021628 | Completed Results

• 1 other identifier: 2018.0296
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The cCHIPS study is a feasibility study for larger scale multi-centre studies and is designed as a single-centre observational cohort, longitudinal, natural history study. The overarching aim of this study is to evaluate the feasibility of performing larger scale, multi-centre studies to evaluate the relationship between CMV shedding in pregnancy with congenital CMV (cCMV). There is no randomisation involved in this study and all participants will perform the same study procedures and receive treatment as usual. The primary (main) objective is to evaluate the prevalence (percentage of occurrence) of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy. The secondary objectives are to evaluate the quantity of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy, to compare the prevalence and quantity of CMV shedding in CMV seropositive women between different sources of shedding (saliva, urine or vaginal secretions) and different gestational stages, to identify risk factors for CMV shedding in CMV seropositive pregnant women, to evaluate the acceptability of the study procedures to the participating pregnant women, to evaluate the proportion of women approached who are recruited into the study and who are completing the study, and to evaluate the relationship between CMV specific cell mediated immunity (a type of immune protection following exposure to CMV) and CMV shedding in CMV seropositive pregnant women. The tertiary objective is to compare the evaluation of CMV specific T cell immune responses (a type of CMV specific cell mediated immunity) between the two commercially available CMV-specific T cell immune response assays which are QuantiFERON-CMV and CMV-ELISPOT assays. This study will aim to recruit 200 pregnant women. This study will be undertaken in parallel with a separate study called RACE-FIT (REC reference number 18/SC/0360, IRAS ID 239977), which will have ethical approval to screen pregnant women with children less than 4 years of age booked for their antenatal care at St George's Hospital, London, identified during the antenatal combined screening bloods appointment or the antenatal booking appointment, for their CMV serology status on a sample of blood collected as part of the screening process. As part of the ethical approval sought for the RACE-FIT study and the cCHIPS study, the pregnant women screened and found to be CMV seronegative will be eligible for recruitment into the RACE-FIT study and those screened and found to be CMV seropositive will be eligible and approached for recruitment into the cCHIPS study. The cCHIPS study aim to recruit over a 6 month period. The study involves four visits (Visit 1, Visit 2, Visit 3, Visit 4) for each participant. The total study period for each participant will be between 6 to 8 months.

Conditions

CMV; Congenital Cmv; Maternal Infections Affecting Fetus or Newborn; Shedding Virus

Keywords

cmv; cytomegalovirus; shedding; excretion; congenital; cCMV; seropositive; maternal

Outcome Measures

Primary Outcomes (1)

• The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy

  The percentage of participants with detectable CMV virus (detected via polymerase chain reaction) in any bodily fluid (saliva, urine or vaginal secretions) at any point in pregnancy, and the percentage of participants with detectable CMV virus in each bodily fluid (saliva, urine and vaginal secretions) at any point in pregnancy.

  8 months

Secondary Outcomes (13)

• The Proportion of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women Throughout Pregnancy and Postpartum

  8 months

• The Quantity of CMV Shedding in Saliva, Urine and Vaginal Secretions in CMV Seropositive Women Throughout Pregnancy and Postpartum

  8 months

• The Proportion of Pregnant Women Approached Who Are Recruited Into the Study

  8 months

• The Proportion of Participating Pregnant Women Completing the Study

  8 months

• The Acceptability of the Study Procedures to Participating Pregnant Women

  8 months

Interventions

No intervention- not applicable OTHER

No intervention - not applicable

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CMV seropositive pregnant women with at least one child of less than four years of age

You may qualify if:

• Pregnant
• CMV seropositive
• Willing and able to provide informed consent
• Living with child(ren), at least one of whom is less than four years old
• Willing to have saliva, urine and vaginal secretion sampling to be tested for CMV PCR
• Willing to be followed up until the postpartum period

You may not qualify if:

• Age less than 18 years
• Evidence of acute maternal CMV infection at the time of screening
• Documented immunodeficiency of any aetiology including the use of oral steroid therapy equivalent to \>1mg/kg of prednisone per day for more than one week
• In the opinion of the investigator is unlikely to comply with the study procedures
• In the opinion of the investigator does not have adequate understanding or verbal and written English

Sponsors & Collaborators

• St George's, University of London: lead
• St George's University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

St George's University Hospitals NHS Foundation Trust

London, SW170RE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA of CMV virus, not human DNA

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Dr Shari Sapuan
• Organization: St George's, University of London

ssapuan@sgul.ac.uk

02086729944

Study Officials

• Shari Sapuan

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 16, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)