Diaplacental Transfer of Anti-HCMV- and Anti-VZV-immunoglobulin G (IgG) -Antibodies at Premature and Mature Newborns

• Conditions: Materno-fetal Transfer of Anti-VZV-IgG; Materno-fetal Transfer of Anti-HCMV-IgG
• Interventions: Other: Blood samples

• Registration Number: NCT02689700
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth.

Detailed Description

For data gathering the investigators measure the main concentration of specific HCMV-/VZV-IgG-antibodies and the concentration of neutralizing IgG-antibodies against HCMV and VZV in maternal blood and in fetal bloodstream. Then the investigators compare the data of mother and newborn. Therefore, the investigators use the following blood samples:

Mother: Venous blood sample taken at birth (+/- three days)

Newborn: Blood sample of umbilical cord (= fetal bloodstream) taken immediately after birth.

The investigators assign the data of each newborn (gestational age at birth) to the data of their respective mother for statistical evaluation. After finishing the study the investigators will destroy all residual blood.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-04
• Last Update Posted: 2017-03-07
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.

Exclusion Criteria

• Newborns of underage mothers.
• Newborns whose mother did not sign the written informed consent.
• Pregnant women with a known hereditary or acquired immune deficiency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VZV antibody-transfer	Blood samples	Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation
HCMV antibody-transfer	Blood samples	Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation

Primary Outcome Measures

Name	Time	Method
To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.	Newborn: immediately after birth; Mother +/- 3 days at birth	Measurement of HCMV and VZV-antibodies in the fetal and the maternal circulation

Secondary Outcome Measures

Name	Time	Method
Gauging the concentration of neutralizing IgG-antibodies against HCMV and VZV in fetal bloodstream depending on gestational age at birth.	Newborn: immediately after birth; Mother +/- 3 days at birth	Measurement of neutralizing IgG-HCMV and VZV-antibodies in the fetal and the maternal circulation

Trial Locations

Locations (1)

Clinic of the Johann Wolfgang-Goethe Univeristy; 🇩🇪 Frankfurt/Main, Hesse, Germany