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Fetal Risk Associated With Rubella Vaccination During Pregnancy

Badilla, Xiomara MQC*; Morice, Ana MD, MPH; Avila-Aguero, Maria L. MD; Saenz, Elizabeth MQC; Cerda, Ilse MD§; Reef, Susan MD§; Castillo-Solórzano, Carlos MD, MPH

The Pediatric Infectious Disease Journal: September 2007 - Volume 26 - Issue 9 - p 830-835
doi: 10.1097/INF.0b013e318124a9f4
Original Studies

Background: Costa Rica implemented a nationwide measles-rubella vaccination campaign among men and women (15–39 years old) in May 2001. A protocol was developed to follow-up the vaccinated women who were unknowingly pregnant, to determine the risk of congenital rubella syndrome (CRS) or congenital rubella infection only associated with the administration of the rubella vaccine RA27/3 during pregnancy.

Methods: To classify the prevaccination maternal immune status, a serum sample was taken at the initial evaluation to detect IgM and IgG rubella antibodies (enzyme-linked immunosorbent assay). All pregnancies were followed up and all newborns were evaluated. A cord serum sample of their children was taken at birth. We calculated odds ratio, OR (95% confidence interval, 95% CI) associated with miscarriage, stillbirth, prematurity, low birth weight, and the presence of defects compatible with CRS.

Results: The prevaccination immune status was established in 797 women and 1191 mother and child pairs were analyzed. Adjusted OR for miscarriage (OR = 0.60, 95% CI = 0.26–1.39), stillbirth (OR = 1.32, 95% CI = 0.10–16.81), prematurity (OR = 0.25, 95% CI = 0.03–2.39), low birth weight (OR = 0.25, 95% CI = 0.03–2.23) and defects compatible with CRS (OR = 1.09, 95% CI = 0.34–3.54) showed no association between immune and susceptible maternal status. There were no cases of CRS and no children were IgM positive.

Conclusions: No adverse pregnancy outcome such as miscarriages or CRS was documented in women who were vaccinated and unknowingly pregnant. These results support RA27/3 rubella vaccine safety.

From the *Social Security System of Costa Rica, San José; †Costa Rican Institute for Research and Training in Nutrition and Health (INCIENSA), Tres Ríos; ‡National Children's Hospital, Dr. Carlos Sáenz Herrera, San Jose, Costa Rica; §Centers for Disease Control and Prevention, Atlanta, GA; and ¶Pan American Health Organization, WA.

Accepted for publication May 23, 2007.

Address for correspondence: Maria L. Avila-Aguero, MD, Costa Rican Ministry of Health, 1654-1000 San Jose, Costa Rica. E-mail:

© 2007 Lippincott Williams & Wilkins, Inc.