Assessment of Alterations in Immune Function During Pregnancy and Post Parturition
- Conditions
- Pregnancy Immune Function
- Registration Number
- NCT01200979
- Brief Summary
Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppression has been characterized as a global T-cell defect, the observation that the increase in susceptibility is restricted only to specific intracellular bacteria and viruses is consistent with a down regulation of only certain components of the innate immune system. Progress in the treatment and management of infections during pregnancy will require further understanding of the changes to the immune system that occur during pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate immune system that occurs during pregnancy and remains until delivery and that changes in serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this study will evaluate blood samples drawn from pregnant women during early, mid, and late pregnancy and post-partum for changes in the innate immune system and compare them to those of healthy, non-pregnant women. Changes in the cytokine profile and in the lymphocyte and natural killer (NK) cell populations will be identified. A comparison of any observed changes will be made with those previously reported for in vitro and in vivo studies.
- Detailed Description
Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppression has been characterized as a global T-cell defect, the observation that the increase in susceptibility is restricted only to specific intracellular bacteria and viruses is consistent with a down regulation of only certain components of the innate immune system. Progress in the treatment and management of infections during pregnancy will require further understanding of the changes to the immune system that occur during pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate immune system that occurs during pregnancy and remains until delivery and that changes in serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this study will evaluate blood samples drawn from pregnant women during early, mid, and late pregnancy and post-partum for changes in the innate immune system and compare them to data on a similar cohort of women of childbearing age from an existing database of healthy, non-pregnant women. Changes in the cytokine profile, gene expression by microarray, and in the lymphocyte and natural killer (NK) cell populations will be identified. We may perform neutrophil analysis. We will evaluate toll-like receptors functionality, and any changes in PBMC throughout pregnancy.
We also plan to evaluate serum cytokine panels, PBMC by flow cytometry, and PBMC for microarray of gene expression, before and after administration of the influenza vaccine in up to 20 of the 40 pregnant subjects. Antibody levels will be measured as well.
A comparison of any observed changes will be made with those previously reported for in vitro and in vivo studies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Cytokine profiles during pregnancy 1st, 2nd, and 3rd trimesters and postpartum and postpartum Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples
Functionality of Toll-like receptors and changes in gene expression 1st, 2nd, and 3rd trimesters and postpartum and postpartum Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum\]
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples. 1st, 2nd, and 3rd trimesters and postpartum and postpartum Changes in lymphocyte and NK cell populations during pregnancy compared to non- pregnant control samples. \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum\]
- Secondary Outcome Measures
Name Time Method Changes in Cytokine profiles Before and after the administration of the influenza vaccine in a subset of pregnant women Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples, in a subset of pregnant women \[Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women\]
Changes in lymphocyte and INK cell populations Before and after the administration of the influenza vaccine in a subset of pregnant women Changes in lymphocyte and INK cell populations during pregnancy compared to non-pregnant control samples, in a subset of pregnant women \[Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women\]
Functionality of Toll-like receptors and changes in gene expression Before and after the administration of the influenza vaccine in a subset of pregnant women Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples, in a subset of pregnant women \[Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women\]
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
🇺🇸Bethesda, Maryland, United States