Antenatal cytomegalovirus (CMV) screening pilot study
- Conditions
- Maternal primary infection with cytomegalovirusReproductive Health and Childbirth - Antenatal care
- Registration Number
- ACTRN12623000710628
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 70
The inclusion criteria for participation in this study are as follows: individuals must be 18 years of age or older, have tested negative for CMV IgG on their antenatal booking bloods performed before 9 weeks and 6 days of gestation, and be no more than 14 weeks and 0 days pregnant at the time of recruitment. Additionally, participants must have the capacity to provide informed consent for medical procedures and either be fluent in English or have access to a qualified interpreter who can explain the study protocol and assist in obtaining informed consent. Furthermore, individuals must have a planned birth at the Mercy Hospital for Women in Victoria, Australia.
The exclusion criteria for participation in this study are as follows: individuals who are younger than 18 years of age are not eligible to participate. Participants who are unable to provide informed consent for medical procedures will be excluded. Individuals who are at or beyond 14 weeks and 0 days of gestation at the time of recruitment are not eligible for inclusion. Lastly, individuals who have a known fetal anomaly in the current pregnancy are not eligible to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Review participant's medical records to evaluate the rate of uptake of CMV serological testing at `10-14 weeks of gestation among pregnant women who were CMV IgG negative at their first antenatal visit.[ At the conclusion of study]
- Secondary Outcome Measures
Name Time Method Participants overall rating of their experience of CMV screening collected using study specific questionnaires (5 point Likert scale).[ at recruitment, between 15 weeks 0 days and 19 weeks 6 days of gestation and within 6 weeks postpartum.];Rate of CMV seroconversion in first trimester assessed by repeating CMV serology between 10-14 weeks of gestation.[ At the conclusion of the study];Audit of patient medical records to determine the uptake rate of valaciclovir therapy among participants who had a documented CMV infection. [ At the conclusion of study];Change in participant's anxiety levels before and after CMV screening assessed using State-Trait Anxiety Inventory.[ at recruitment, between 15 weeks 0 days and 19 weeks 6 days of gestation and within 6 weeks postpartum.];Participants preferences for clinical management collected using medical records.[ At conclusion of the study.]