CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Blood sample +4 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01251744
NCT01251744N/ACompleted

Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

GlaxoSmithKline·interventional·Posted Dec 2, 2010·Updated Jun 29, 2020

In Brief

A clinical study evaluating Blood sample, Cord blood sample, and 3 other interventions for Infections, Cytomegalovirus and Cytomegalovirus Infections. Completed, enrolled 160 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartDec 9, 2010
Primary CompletionNov 6, 2013
Study CompletionJun 17, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.6 years ago

Interventions

Blood sampleprocedure

Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

Cord blood sampleprocedure

Cord blood sample taken at the time of delivery.

Saliva swabprocedure

Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

Urine samplingprocedure

Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

Vaginal swabprocedure

Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.