A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Public ClinicalTrials.gov record NCT01376778. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.
Study identification
- NCT ID
- NCT01376778
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 399 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2012
- Primary completion
- Sep 30, 2019
- Completion
- Jun 29, 2021
- Last update posted
- Feb 1, 2023
2012 – 2021
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | — |
| Stanford University | Stanford | California | 94305-5317 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Columbia University | New York | New York | 10032 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Case Western Reserve-Metrohealth | Cleveland | Ohio | 44109 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Brown University | Providence | Rhode Island | 02905 | — |
| University of Texas - Southwestern Medical Center | Dallas | Texas | 75235 | — |
| University of Texas - Galveston | Galveston | Texas | 77555 | — |
| University of Texas - Houston | Houston | Texas | 77030 | — |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01376778, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01376778 live on ClinicalTrials.gov.