Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
This study is currently recruiting participants.
Verified October 2011 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
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
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| First Received Date ICMJE | October 7, 2011 | ||||||||
| Last Updated Date | October 16, 2011 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01450059 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section | ||||||||
| Official Title ICMJE | Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section | ||||||||
| 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. |
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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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Umbilical Cord blood Blood from peripheral vene |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section. |
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| Condition ICMJE | Human Immunodeficiency Virus | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | August 2014 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: • HiV exposed Newborns with normal risk of HiV transmission. Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 10 Minutes | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01450059 | ||||||||
| Other Study ID Numbers ICMJE | 31082011 FRA Mat Fet Chim | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospitals | ||||||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||||||
| Verification Date | October 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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