Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Maternal CD4+ t-cells in HiV exposed Newborns [Six weeks after date of birth]
The maternal CD4+ t-cells are measured by microchimersimanalysis
Secondary Outcome Measures
- HiV transmission rate [6 month after birth]
Measurement of HiV PCR at the age of 6 month after birth
- Analysis of HiV in maternal CD4+ t-cells [2 month after delivery]
HiV-PCR analysis from maternal CD4+ cells
- Measurement of maternal CD8+ t-cells in the Newborn [6 weeks]
Measurement of maternal CD8+ t-cells by microchimerismanalysis
Eligibility Criteria
Criteria
Inclusion Criteria:
• HiV exposed Newborns with normal risk of HiV transmission.
Exclusion Criteria:
-
HiV exposed Newborns wiht elevated or high risk of HiV transmission.
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HiV exposed Newborns of mothers not full of age.
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missing informed consent of at least the mother
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Outborns
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Asphyxia
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Major congenital defects
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Chromosomal anomalies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic of the Johann Wolfgang-Goethe Univeristy | Frankfurt/Main | Hesse | Germany | 60590 |
Sponsors and Collaborators
- Johann Wolfgang Goethe University Hospital
Investigators
- Principal Investigator: Horst Buxmann, Dr. med., Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology
Study Documents (Full-Text)
None provided.More Information
Publications
- European Collaborative Study, Boer K, England K, Godfried MH, Thorne C. Mode of delivery in HIV-infected pregnant women and prevention of mother-to-child transmission: changing practices in Western Europe. HIV Med. 2010 Jul 1;11(6):368-78. doi: 10.1111/j.1468-1293.2009.00800.x. Epub 2010 Jan 4.
- Gemeinsame Erklärung* der Deutschen AIDS-Gesellschaft (DAIG); Osterreichischen AIDS-Gesellschaft (OAG); Kompetenznetzes HIV/AIDS sowie des Robert-Koch-Institutes Berlin (RKI); Deutschen Arbeitsgemeinschaft niederniedergelassener Arzte in der Versorgung von HIV-und AIDS-Patienten (DAGNA); Deutschen Gesellschaft für Kinderheilkunde und Jugendmedizin (DGKJ); Pädiatrischen Arbeitsgemeinschaft AIDS Deutschland (PAAD); Deutschen Gesellschaft für Gynäkologie und Geburtshilfe (DGGG); Nationalen Referenzzentrums für Retroviren (NRZ) der Deutschen AIDS-Hilfe (DAH). [German-Austrian recommendations for HIV treatment during pregnancy and for newborns exposed to HIV--Update 2008]. Dtsch Med Wochenschr. 2009 Jan;134 Suppl 1:S40-54. doi: 10.1055/s-0028-1123974. Epub 2009 Jan 26. Review. German.
- Willasch A, Schneider G, Reincke BS, Shayegi N, Kreyenberg H, Kuci S, Weber G, Van Der Reijden B, Niethammer D, Klingebiel T, Bader P. Sequence polymorphism systems for quantitative real-time polymerase chain reaction to characterize hematopoietic chimerism-high informativity and sensitivity as well as excellent reproducibility and precision of measurement. Lab Hematol. 2007;13(3):73-84.
- 31082011 FRA Mat Fet Chim