Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone

Study Overview
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Brief Summary
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The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic cells (DC).

Official Title
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Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone

Conditions
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Obstetric Labor, Premature

Intervention / Treatment
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* Biological: Culture with progesterone
* Biological: Culture without progesterone
* Biological: Culture with growth factors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Placentas from term and preterm deliveries Singleton pregnancy Consent to participate Exclusion Criteria: Pregnancies with obstetric complications Multiple gestation Maternal illness or fetal malformation known pre-delivery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preterm labor placentas and progesterone<br>IMC cells taken from preterm labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with progesterone<br>* Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells<br>|
| Active Comparator: Term labor placentas and progesterone<br>IMC cells taken from term labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with progesterone<br>* Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells<br>|
| Active Comparator: Preterm labor placentas without progesterone<br>IMC cells taken from preterm labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture without progesterone<br>* Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone<br>|
| Active Comparator: Term labor placentas without progesterone<br>IMC cells taken from term labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture without progesterone<br>* Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone<br>|
| Active Comparator: Term placentas from progesterone treated pregnancies<br>IMC cells taken from term labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with growth factors<br>* Culture of placental IMC cells with growth hormones only and analysis<br>|
| Active Comparator: Preterm placentas from progesterone treated pregnancies<br>IMC cells taken from preterm labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with growth factors<br>* Culture of placental IMC cells with growth hormones only and analysis<br>|
| Active Comparator: Term placentas not treated with progesterone in pregnancy<br>IMC cells taken from term placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with growth factors<br>* Culture of placental IMC cells with growth hormones only and analysis<br>|
| Active Comparator: Preterm placentas not treated with progesterone in pregnancy<br>IMC cells taken from preterm placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with growth factors<br>* Culture of placental IMC cells with growth hormones only and analysis<br>|
| Active Comparator: Term postpartum blood samples with progesterone<br>CD-14+ monocyte cells taken from women delivering at term will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with progesterone<br>* Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells<br>|
| Active Comparator: Preterm postpartum blood samples with progesterone<br>CD-14+ monocyte cells taken from women delivering preterm will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture with progesterone<br>* Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells<br>|
| Active Comparator: Term postpartum blood samples without progesterone<br>CD-14+ monocyte cells taken from women delivering at term will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture without progesterone<br>* Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone<br>|
| Active Comparator: Preterm postpartum blood samples without progesterone<br>CD-14+ monocyte cells taken from women delivering preterm will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. | Biological: Culture without progesterone<br>* Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation characteristic effects of progesterone on preterm and term placentas | Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone | One year | 
| Maturation effects of progesterone on preterm and term placentas | Differences observed in maturation of IMC cells into DC cells in term and preterm placentas | One year |