Study Goal: to determine whether maternal administration of CMV hyperimmune globulin prior to 24 weeks gestation in women diagnosed with primary CMV infection reduces the rate of congenital CMV infection

Status: Currently enrolling

Enrollment: March 2012-March 2016

Design Type: Double masked randomized clinical trial stratified by clinical center

Major Eligibility Criteria:
Singleton pregnancy
Gestational age < 24 weeks
Primary CMV infection

Study Medication Groups:
Active: CMV hyperimmune globulin at dose of 100mg/kg body weight
Placebo: Matching injection (Albumin 5% D5W)

Sample Size: 800

Randomization:
Pregnancy, exposure, medical history
Blood (20ml) and urine (20ml) for storage

Post-Randomization: Every 4 weeks: infusion of study medication, assess side effects and open-label use
Blood (5ml) and urine (5ml) for storage

Post-Infusion: Phone call to patient @ 4-8 hours after the end of the first infusion (first 50 patients only)
Phone call to patient @ 16-24 hours after the end of all infusions

Delivery: Delivery and neonatal data

Follow-Up:
Urine and saliva on infants by 3 weeks
Hearing by one month
Developmental, hearing, and saliva testing of infant @ years 1 and 2

Primary Outcome: Fetal loss or congenital CMV infection diagnosed by urine or saliva by 3 weeks of age

For more information, contact Tammy Bishop at 919-668-7475.