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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Examination of Diaplacental Transfer of IgG-antibodies Against Human Cytomegalovirus (HCMV) and Varicella-Zoster-Virus (VZV) at Premature and Mature Newborns

Conditions
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Materno-fetal Transfer of Anti-HCMV-IgG, Materno-fetal Transfer of Anti-VZV-IgG

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 10 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCMV antibody-transfer<br>Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation | Other: Blood samples<br>* Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.<br>|
| VZV antibody-transfer<br>Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation | Other: Blood samples<br>* Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Cytomegalovirus, Varicella Zoster Virus, Materno-fetal antibody transfer, Pregnancy, Gestational age