Primary Prevention of Cytomegalovirus in Pregnancy: Addressing the Gaps (CMV GAP)
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 主要终点
- The seroincidence of primary CMV infection in the first trimester of pregnancy
研究概览
简要总结
CMV is the most common congenital infection (an infection acquired before birth) in the UK. It is the leading non-genetic cause of sensorineural (inner ear) hearing loss and a common cause of neuro-disability. Congenital CMV is associated with an estimated cost of £732 million each year in the UK.
The risk of acquiring CMV in pregnancy may be reduced by making simple adaptions to behaviours to avoid direct contact with saliva and urine of young children. There are currently no national policies that recommend CMV risk reduction measures in pregnancy.
The overarching aim of project is to establish and build effective partnerships with policy makers and stakeholders to identify policy priorities and to gather the essential evidence required to fully inform policies to reduce the risk of CMV infection in pregnancy.
The specific objective of this element of the overall project is to determine the proportion of women at risk of primary CMV infection in pregnancy and the rates of primary CMV infection in the first trimester of pregnancy by testing blood samples routinely collected at antenatal booking at representative sites in England.
In partnership with University Hospital Southampton NHS Foundation Trust Specialist Virology Laboratory, investigators will carry out a CMV serosurvey using stored antenatal serum from pregnant women across England. Investigators will test these samples at the point at which they would otherwise be destroyed. This will enable investigators to determine the proportion of women who are seronegative, as this is the group that will be enrolled in future intervention studies (both educational and also vaccine studies). This information is required to accurately inform the power calculation for large efficacy studies. This will also allow investigators to determine the proportion of women who acquire CMV in the first trimester of pregnancy - thus demonstrating the consequences of policy inaction.
详细描述
Ten children are born every day in the UK with congenital cytomegalovirus (CMV) infection. Over half of infants who have symptoms or signs of CMV at birth have moderate to severe long-term impairments such as hearing loss or neurodisability; of those infants who appear well at birth, nearly 1 in 5 have long-term adverse sequalae. The impact on these families is immense, even for those families whose child has normal hearing and development, as the outcomes are often unpredictable at birth. The cost of CMV in the UK is around £732 million each year.
CMV infection in healthy individuals is often asymptomatic or associated with mild flu-like symptoms and therefore the infection may not be diagnosed in pregnancy. If a woman has a primary CMV infection (i.e. never had CMV infection before, termed 'seronegative'), the risk of transmission to the infant is around 32%; the risk is lower in those women who had had CMV infection previously (CMV IgG antibodies present, termed 'seropositive'), in the order of 1%. Acquisition of CMV infection in the first trimester of pregnancy is associated with the highest risk of adverse outcomes for the infant.
The risk of acquiring CMV in pregnancy can be reduced by making simple adaptions to behaviours to avoid direct contact with saliva and urine of young children - who are the most common transmitters of CMV infection to pregnant women. For example: tasting food first and not eating a young child's left-over food; or kissing on the forehead instead of on the lips; handwashing after nappy changes.
Despite CMV being the most common congenital infection and the leading infectious cause of sensorineural hearing loss and neurodisability, it is much less well known than other conditions that occur at a lower frequency, such as Down's Syndrome.
However, the majority of antenatal care providers do not include information about CMV to women alongside information about how to prevent other, much less common conditions, such as toxoplasmosis. There are currently no national policies that recommend CMV risk reduction measures in pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Antenatal sera collected in the designated sites within the first 16 weeks of pregnancy and collected within a two-month period between 1st April 2019 and 1st October 2019 inclusive.
排除标准
- •There are no exclusion criteria other than inability to fulfil the inclusion criteria above.
结局指标
主要结局
The seroincidence of primary CMV infection in the first trimester of pregnancy
时间窗: 31/12/2021
Proportion of samples that are IgG+, IgM+ with low IgG avidity
The seroprevalence of CMV in sera collected in the first trimester of pregnancy
时间窗: 31/12/2021
Proportion of samples that are CMV IgG+
次要结局
未报告次要终点
