NCT01251744

Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.

Conditions

• Infections, Cytomegalovirus
• Cytomegalovirus Infections

Interventions

Type	Name	Description
PROCEDURE	Blood sample	Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
PROCEDURE	Cord blood sample	Cord blood sample taken at the time of delivery.
PROCEDURE	Saliva swab	Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
PROCEDURE	Urine sampling	Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
PROCEDURE	Vaginal swab	Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.

Timeline

• Start date: 2010-12-09
• Primary completion: 2013-11-06
• Completion: 2015-06-17
• First posted: 2010-12-02
• Last updated: 2020-06-29
• Results posted: 2020-01-02

Locations

9 sites across 1 country: Belgium