Limits...
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

Overview of the study design. Participation in the study was restricted to adult (> 18 years of age) Italian pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation and at risk for CMV infection. Interpretation of IgM-positive results and prenatal or neonatal diagnosis of congenital CMV infection in case of maternal seroconversion or primary infection in the first trimester of gestation were performed outside of the present study as part of routine care in case of suspected or confirmed primary CMV infection (dotted boxes).
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4588434&req=5

f0005: Overview of the study design. Participation in the study was restricted to adult (> 18 years of age) Italian pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation and at risk for CMV infection. Interpretation of IgM-positive results and prenatal or neonatal diagnosis of congenital CMV infection in case of maternal seroconversion or primary infection in the first trimester of gestation were performed outside of the present study as part of routine care in case of suspected or confirmed primary CMV infection (dotted boxes).

Mentions: The study included a prospective intervention group and an observational comparison group (Fig. 1). Details regarding the identification of women at risk for CMV infection together with eligibility criteria are reported in the Suppl. data. Briefly, in the intervention group, all consecutive pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation during the study period were assessed for risk factors for CMV infection. Women were considered at risk if they had their own child or had frequent contacts with children other than their own of less than 36 months of age. Pregnant women working with children of the same age group either full time or part time (health care or child care providers) together with pregnant women of less than 20 years of age were also considered at risk. Women, who were either CMV-seronegative or not previously tested for CMV immune status, were invited to participate in the study. Susceptible women received information about CMV and preventive measures, and were prospectively monitored for CMV antibody at 18 weeks of gestation and at delivery. In case of primary CMV infection diagnosed either at enrollment or at 18 weeks of gestation, the option of prenatal diagnosis was discussed and pregnancy managed accordingly. In the absence of maternal infection, women received standard prenatal care according to Italian guidelines (www.snlg-iss.it/lgn_gravidanza_fisiologica_agg_2011).


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)

Overview of the study design. Participation in the study was restricted to adult (> 18 years of age) Italian pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation and at risk for CMV infection. Interpretation of IgM-positive results and prenatal or neonatal diagnosis of congenital CMV infection in case of maternal seroconversion or primary infection in the first trimester of gestation were performed outside of the present study as part of routine care in case of suspected or confirmed primary CMV infection (dotted boxes).
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

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

f0005: Overview of the study design. Participation in the study was restricted to adult (> 18 years of age) Italian pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation and at risk for CMV infection. Interpretation of IgM-positive results and prenatal or neonatal diagnosis of congenital CMV infection in case of maternal seroconversion or primary infection in the first trimester of gestation were performed outside of the present study as part of routine care in case of suspected or confirmed primary CMV infection (dotted boxes).
Mentions: The study included a prospective intervention group and an observational comparison group (Fig. 1). Details regarding the identification of women at risk for CMV infection together with eligibility criteria are reported in the Suppl. data. Briefly, in the intervention group, all consecutive pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation during the study period were assessed for risk factors for CMV infection. Women were considered at risk if they had their own child or had frequent contacts with children other than their own of less than 36 months of age. Pregnant women working with children of the same age group either full time or part time (health care or child care providers) together with pregnant women of less than 20 years of age were also considered at risk. Women, who were either CMV-seronegative or not previously tested for CMV immune status, were invited to participate in the study. Susceptible women received information about CMV and preventive measures, and were prospectively monitored for CMV antibody at 18 weeks of gestation and at delivery. In case of primary CMV infection diagnosed either at enrollment or at 18 weeks of gestation, the option of prenatal diagnosis was discussed and pregnancy managed accordingly. In the absence of maternal infection, women received standard prenatal care according to Italian guidelines (www.snlg-iss.it/lgn_gravidanza_fisiologica_agg_2011).

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