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Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01450059
Enrollment
54
Registered
2011-10-12
Start date
2011-08-31
Completion date
2015-08-31
Last updated
2016-02-22

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

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus, Microchimerism, Maternal-Fetal Exchange, Gestation, HiV-vertical transmission

Brief summary

The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed Newborns after spontaneous birth in comparison to cesarean section. This may have an influence on the risk of vertical HiV transmission.

Detailed description

At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis. After 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood. Additionally we look for HiV in maternal CD4+ t-cells.

Interventions

None listed

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
No

Inclusion criteria

• HiV exposed Newborns with normal risk of HiV transmission.

Exclusion criteria

* HiV exposed Newborns wiht elevated or high risk of HiV transmission. * HiV exposed Newborns of mothers not full of age. * missing informed consent of at least the mother * Outborns * Asphyxia * Major congenital defects * Chromosomal anomalies

Design outcomes

Primary

MeasureTime frameDescription
Maternal CD4+ t-cells in HiV exposed NewbornsSix weeks after date of birthThe maternal CD4+ t-cells are measured by microchimersimanalysis

Secondary

MeasureTime frameDescription
Analysis of HiV in maternal CD4+ t-cells2 month after deliveryHiV-PCR analysis from maternal CD4+ cells
Measurement of maternal CD8+ t-cells in the Newborn6 weeksMeasurement of maternal CD8+ t-cells by microchimerismanalysis
HiV transmission rate6 month after birthMeasurement of HiV PCR at the age of 6 month after birth

Countries

Germany

Outcome results

None listed

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