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

Status

Completed

Conditions

Human Immunodeficiency Virus

Study type

Observational

Funder types

Other

Identifiers

NCT01450059
31082011 FRA Mat Fet Chim

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

1 to 10 minutes old

Volunteers

No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

Spontaneous delivery
Description:
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery.
Cesarean section
Description:
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section.

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Feb 22, 2016

Start date

Aug 01, 2011 • 13 years ago

End date

Apr 01, 2014 • 10 years ago

Today

Jan 20, 2025

Sponsor of this trial

Data sourced from clinicaltrials.gov