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Prevention of Primary Cytomegalovirus Infection in Pregnancy.

Revello MG, Tibaldi C, Masuelli G, Frisina V, Sacchi A, Furione M, Arossa A, Spinillo A, Klersy C, Ceccarelli M, Gerna G, Todros T, CCPE Study Gro - EBioMedicine (2015)

Bottom Line: The primary outcome was CMV seroconversion.Four out of 331 (1.2%) women seroconverted in the intervention group compared to 24/315 (7.6%) in the comparison group (delta = 6.4%; 95% CI 3.2-9.6; P < 0.001).While waiting for CMV vaccine to become available, the intervention described may represent a responsible and acceptable primary prevention strategy to reduce congenital CMV.

View Article: PubMed Central - PubMed

Affiliation: Departments of Obstetrics and Gynecology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.

ABSTRACT

Background: Cytomegalovirus (CMV) is the leading infectious agent causing congenital sensorineural hearing loss and psychomotor retardation. CMV vaccine is currently unavailable and treatment options in pregnancy are limited. Susceptible pregnant women caring for children are at high risk for primary infection. CMV educational and hygienic measures have the potential to prevent primary maternal infection.

Methods: A mixed interventional and observational controlled study was conducted to investigate the effectiveness of hygiene information among pregnant women at risk for primary CMV infection for personal/occupational reasons. In the intervention arm, CMV-seronegative women, identified at the time of maternal serum screening for fetal aneuploidy at 11-12 weeks of gestation, were given hygiene information and prospectively tested for CMV until delivery. The comparison arm consisted of women enrolled at delivery who were neither tested for nor informed about CMV during pregnancy, and who had a serum sample stored at the screening for fetal aneuploidy. By design, groups were homogeneous for age, parity, education, and exposure to at least one risk factor. The primary outcome was CMV seroconversion. Acceptance of hygiene recommendations was a secondary objective and was measured by a self-report.

Findings: Four out of 331 (1.2%) women seroconverted in the intervention group compared to 24/315 (7.6%) in the comparison group (delta = 6.4%; 95% CI 3.2-9.6; P < 0.001). There were 3 newborns with congenital infection in the intervention group and 8 in the comparison group (1 with cerebral ultrasound abnormalities at birth). Ninety-three percent of women felt hygiene recommendations were worth suggesting to all pregnant women at risk for infection.

Interpretation: This controlled study provides evidence that an intervention based on the identification and hygiene counseling of CMV-seronegative pregnant women significantly prevents maternal infection. While waiting for CMV vaccine to become available, the intervention described may represent a responsible and acceptable primary prevention strategy to reduce congenital CMV.

No MeSH data available.


Related in: MedlinePlus

Enrollment and outcome. Interventio group. Twenty-one women found to be CMV IgM-positive at enrollment were further tested for IgG avidity (dotted box). Avidity index was high (> 45%), thus excluding a primary CMV infection, in the previous 3 months in 15 women. One woman had avidity in the intermediate range (25%–45%), indicating a possible primary infection in the past 6 months, and 5 women had low (< 25%) avidity indexes compatible with a recent (< 3 months) primary infection. Two women diagnosed with primary infection in the first trimester of gestation opted for prenatal diagnosis of congenital CMV infection and amniocentesis was performed at 20 weeks of gestation.
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f0010: Enrollment and outcome. Interventio group. Twenty-one women found to be CMV IgM-positive at enrollment were further tested for IgG avidity (dotted box). Avidity index was high (> 45%), thus excluding a primary CMV infection, in the previous 3 months in 15 women. One woman had avidity in the intermediate range (25%–45%), indicating a possible primary infection in the past 6 months, and 5 women had low (< 25%) avidity indexes compatible with a recent (< 3 months) primary infection. Two women diagnosed with primary infection in the first trimester of gestation opted for prenatal diagnosis of congenital CMV infection and amniocentesis was performed at 20 weeks of gestation.

Mentions: In the intervention arm, 4096 consecutive Italian pregnant women undergoing genetic screening were assessed for eligibility (Fig. 2). Overall, 745 were enrolled and tested for CMV antibody. Of these, 381 (51%) women were found to be CMV-seronegative and received CMV information and hygiene counseling. During the study, 13 women had a spontaneous abortion between 12 and 18 weeks of gestation. Four of these women were not further tested, whereas 9 were still CMV-seronegative about one year after completion of the study. In addition, 37 (23 + 14) women were lost to follow-up. Two women seroconverted between 12 and 18 weeks of gestation and 2 between 18 weeks and delivery. Overall, 4 of the 331 women who completed the study seroconverted (1.2%; 95% CI 0.3–3.1). Detailed information about these 4 women is reported in Table 1 (Suppl. data). In 5 women, CMV-specific IgM and IgG of low avidity indicating a primary CMV infection acquired in the first trimester of gestation were detected when they were first tested at 11–12 weeks of gestation (Fig. 2).


Prevention of Primary Cytomegalovirus Infection in Pregnancy.

Revello MG, Tibaldi C, Masuelli G, Frisina V, Sacchi A, Furione M, Arossa A, Spinillo A, Klersy C, Ceccarelli M, Gerna G, Todros T, CCPE Study Gro - EBioMedicine (2015)

Enrollment and outcome. Interventio group. Twenty-one women found to be CMV IgM-positive at enrollment were further tested for IgG avidity (dotted box). Avidity index was high (> 45%), thus excluding a primary CMV infection, in the previous 3 months in 15 women. One woman had avidity in the intermediate range (25%–45%), indicating a possible primary infection in the past 6 months, and 5 women had low (< 25%) avidity indexes compatible with a recent (< 3 months) primary infection. Two women diagnosed with primary infection in the first trimester of gestation opted for prenatal diagnosis of congenital CMV infection and amniocentesis was performed at 20 weeks of gestation.
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4588434&req=5

f0010: Enrollment and outcome. Interventio group. Twenty-one women found to be CMV IgM-positive at enrollment were further tested for IgG avidity (dotted box). Avidity index was high (> 45%), thus excluding a primary CMV infection, in the previous 3 months in 15 women. One woman had avidity in the intermediate range (25%–45%), indicating a possible primary infection in the past 6 months, and 5 women had low (< 25%) avidity indexes compatible with a recent (< 3 months) primary infection. Two women diagnosed with primary infection in the first trimester of gestation opted for prenatal diagnosis of congenital CMV infection and amniocentesis was performed at 20 weeks of gestation.
Mentions: In the intervention arm, 4096 consecutive Italian pregnant women undergoing genetic screening were assessed for eligibility (Fig. 2). Overall, 745 were enrolled and tested for CMV antibody. Of these, 381 (51%) women were found to be CMV-seronegative and received CMV information and hygiene counseling. During the study, 13 women had a spontaneous abortion between 12 and 18 weeks of gestation. Four of these women were not further tested, whereas 9 were still CMV-seronegative about one year after completion of the study. In addition, 37 (23 + 14) women were lost to follow-up. Two women seroconverted between 12 and 18 weeks of gestation and 2 between 18 weeks and delivery. Overall, 4 of the 331 women who completed the study seroconverted (1.2%; 95% CI 0.3–3.1). Detailed information about these 4 women is reported in Table 1 (Suppl. data). In 5 women, CMV-specific IgM and IgG of low avidity indicating a primary CMV infection acquired in the first trimester of gestation were detected when they were first tested at 11–12 weeks of gestation (Fig. 2).

Bottom Line: The primary outcome was CMV seroconversion.Four out of 331 (1.2%) women seroconverted in the intervention group compared to 24/315 (7.6%) in the comparison group (delta = 6.4%; 95% CI 3.2-9.6; P < 0.001).While waiting for CMV vaccine to become available, the intervention described may represent a responsible and acceptable primary prevention strategy to reduce congenital CMV.

View Article: PubMed Central - PubMed

Affiliation: Departments of Obstetrics and Gynecology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.

ABSTRACT

Background: Cytomegalovirus (CMV) is the leading infectious agent causing congenital sensorineural hearing loss and psychomotor retardation. CMV vaccine is currently unavailable and treatment options in pregnancy are limited. Susceptible pregnant women caring for children are at high risk for primary infection. CMV educational and hygienic measures have the potential to prevent primary maternal infection.

Methods: A mixed interventional and observational controlled study was conducted to investigate the effectiveness of hygiene information among pregnant women at risk for primary CMV infection for personal/occupational reasons. In the intervention arm, CMV-seronegative women, identified at the time of maternal serum screening for fetal aneuploidy at 11-12 weeks of gestation, were given hygiene information and prospectively tested for CMV until delivery. The comparison arm consisted of women enrolled at delivery who were neither tested for nor informed about CMV during pregnancy, and who had a serum sample stored at the screening for fetal aneuploidy. By design, groups were homogeneous for age, parity, education, and exposure to at least one risk factor. The primary outcome was CMV seroconversion. Acceptance of hygiene recommendations was a secondary objective and was measured by a self-report.

Findings: Four out of 331 (1.2%) women seroconverted in the intervention group compared to 24/315 (7.6%) in the comparison group (delta = 6.4%; 95% CI 3.2-9.6; P < 0.001). There were 3 newborns with congenital infection in the intervention group and 8 in the comparison group (1 with cerebral ultrasound abnormalities at birth). Ninety-three percent of women felt hygiene recommendations were worth suggesting to all pregnant women at risk for infection.

Interpretation: This controlled study provides evidence that an intervention based on the identification and hygiene counseling of CMV-seronegative pregnant women significantly prevents maternal infection. While waiting for CMV vaccine to become available, the intervention described may represent a responsible and acceptable primary prevention strategy to reduce congenital CMV.

No MeSH data available.


Related in: MedlinePlus