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

J

Johann Wolfgang Goethe University Hospital

Status

Unknown

Conditions

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

Treatments

Other: Blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT02689700
040713 FRA Mat Fet CMV Antib

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

1 to 10 minutes old

Volunteers

Accepts Healthy Volunteers

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

Trial design

450 participants in 2 patient groups

HCMV antibody-transfer
Description:
Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation
Treatment:
Other: Blood samples
VZV antibody-transfer
Description:
Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation
Treatment:
Other: Blood samples

Trial contacts and locations

1

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Central trial contact

Clara A Lüdeke, SI; Horst Buxmann, PI

Data sourced from clinicaltrials.gov

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