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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01450059
First received: October 7, 2011
Last updated: October 16, 2011
Last verified: October 2011

October 7, 2011
October 16, 2011
August 2011
August 2013   (final data collection date for primary outcome measure)
Maternal CD4+ t-cells in HiV exposed Newborns [ Time Frame: Six weeks after date of birth ] [ Designated as safety issue: Yes ]
The maternal CD4+ t-cells are measured by microchimersimanalysis
Same as current
Complete list of historical versions of study NCT01450059 on ClinicalTrials.gov Archive Site
  • HiV transmission rate [ Time Frame: 6 month after birth ] [ Designated as safety issue: Yes ]
    Measurement of HiV PCR at the age of 6 month after birth
  • Analysis of HiV in maternal CD4+ t-cells [ Time Frame: 2 month after delivery ] [ Designated as safety issue: Yes ]
    HiV-PCR analysis from maternal CD4+ cells
  • Measurement of maternal CD8+ t-cells in the Newborn [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measurement of maternal CD8+ t-cells by microchimerismanalysis
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Umbilical Cord blood Blood from peripheral vene

Non-Probability Sample

Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.

Human Immunodeficiency Virus
Not Provided
  • Spontaneous delivery
    Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery.
  • Cesarean section
    Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
up to 10 Minutes
No
Contact: Horst Buxmann, Dr. med. 0049 69 6301 ext 5247 horst.buxmann@kgu.de
Contact: Rolf L Schloesser, Prof Dr med 0049 69 6301 ext 5120 rolf.schloesser@kgu.de
Germany
 
NCT01450059
31082011 FRA Mat Fet Chim
No
Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Horst Buxmann, Dr. med. Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology
Johann Wolfgang Goethe University Hospitals
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP