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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02689700
Acronym
MoChi-HCMV
Enrollment
450
Registered
2016-02-24
Start date
2013-07-31
Completion date
2018-07-31
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Human Cytomegalovirus, Varicella Zoster Virus, Materno-fetal antibody transfer, Pregnancy, Gestational age

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.

Interventions

OTHERBlood samples

Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 10 Minutes
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 birthMeasurement of HCMV and VZV-antibodies in the fetal and the maternal circulation

Secondary

MeasureTime frameDescription
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 birthMeasurement of neutralizing IgG-HCMV and VZV-antibodies in the fetal and the maternal circulation

Countries

Germany

Contacts

Primary ContactHorst Buxmann, PI
horst.buxmann@kgu.de+49 69 6301
Backup ContactClara A Lüdeke, SI
clara.luedeke@web.de+49 17662403039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026