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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. Comparison group. In the comparison group, 56 women were excluded because they were CMV-seronegative at the beginning of pregnancy, they received hygiene information and were monitored for CMV during pregnancy. Fourteen women who tested IgM-positive on stored serum samples at 11–12 weeks of gestation were also tested for avidity of CMV-specific IgG (dotted box). A low avidity index indicating a primary infection acquired in the first trimester of gestation was found in 4 of them. Of the 24 women who seroconverted during pregnancy, 4 were IgM-negative when tested at delivery. All the 291 CMV-seronegative women at delivery received CMV counseling.
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f0015: Enrollment and outcome. Comparison group. In the comparison group, 56 women were excluded because they were CMV-seronegative at the beginning of pregnancy, they received hygiene information and were monitored for CMV during pregnancy. Fourteen women who tested IgM-positive on stored serum samples at 11–12 weeks of gestation were also tested for avidity of CMV-specific IgG (dotted box). A low avidity index indicating a primary infection acquired in the first trimester of gestation was found in 4 of them. Of the 24 women who seroconverted during pregnancy, 4 were IgM-negative when tested at delivery. All the 291 CMV-seronegative women at delivery received CMV counseling.

Mentions: In the comparison arm, of the 4732 women assessed for eligibility at 36–37 weeks of gestation or at delivery, 533 were enrolled (Fig. 3). Of these women, 315 (59%) were found to be CMV-seronegative on serum samples stored at 11–12 weeks of gestation. When retested around or at delivery, it was found that 24 women had seroconverted during pregnancy (7.6%, 95% CI 4.9–11.1). Characteristics of these women are reported in Table 2 (Suppl. data). Four additional women were retrospectively diagnosed with a primary CMV infection acquired in the first trimester of gestation on the basis of CMV-specific IgM and IgG of low avidity (Fig. 3).


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. Comparison group. In the comparison group, 56 women were excluded because they were CMV-seronegative at the beginning of pregnancy, they received hygiene information and were monitored for CMV during pregnancy. Fourteen women who tested IgM-positive on stored serum samples at 11–12 weeks of gestation were also tested for avidity of CMV-specific IgG (dotted box). A low avidity index indicating a primary infection acquired in the first trimester of gestation was found in 4 of them. Of the 24 women who seroconverted during pregnancy, 4 were IgM-negative when tested at delivery. All the 291 CMV-seronegative women at delivery received CMV counseling.
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

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

f0015: Enrollment and outcome. Comparison group. In the comparison group, 56 women were excluded because they were CMV-seronegative at the beginning of pregnancy, they received hygiene information and were monitored for CMV during pregnancy. Fourteen women who tested IgM-positive on stored serum samples at 11–12 weeks of gestation were also tested for avidity of CMV-specific IgG (dotted box). A low avidity index indicating a primary infection acquired in the first trimester of gestation was found in 4 of them. Of the 24 women who seroconverted during pregnancy, 4 were IgM-negative when tested at delivery. All the 291 CMV-seronegative women at delivery received CMV counseling.
Mentions: In the comparison arm, of the 4732 women assessed for eligibility at 36–37 weeks of gestation or at delivery, 533 were enrolled (Fig. 3). Of these women, 315 (59%) were found to be CMV-seronegative on serum samples stored at 11–12 weeks of gestation. When retested around or at delivery, it was found that 24 women had seroconverted during pregnancy (7.6%, 95% CI 4.9–11.1). Characteristics of these women are reported in Table 2 (Suppl. data). Four additional women were retrospectively diagnosed with a primary CMV infection acquired in the first trimester of gestation on the basis of CMV-specific IgM and IgG of low avidity (Fig. 3).

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