Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Maturation effects of progesterone on preterm and term placentas
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Preterm labor placentas and progesterone
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.
Intervention: Culture with progesterone (Biological)
Term labor placentas and progesterone
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.
Intervention: Culture with progesterone (Biological)
Preterm labor placentas without progesterone
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.
Intervention: Culture without progesterone (Biological)
Term labor placentas without progesterone
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.
Intervention: Culture without progesterone (Biological)
Term placentas from progesterone treated pregnancies
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.
Intervention: Culture with growth factors (Biological)
Preterm placentas from progesterone treated pregnancies
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.
Intervention: Culture with growth factors (Biological)
Term placentas not treated with progesterone in pregnancy
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.
Intervention: Culture with growth factors (Biological)
Preterm placentas not treated with progesterone in pregnancy
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.
Intervention: Culture with growth factors (Biological)
Term postpartum blood samples with progesterone
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.
Intervention: Culture with progesterone (Biological)
Preterm postpartum blood samples with progesterone
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.
Intervention: Culture with progesterone (Biological)
Term postpartum blood samples without progesterone
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.
Intervention: Culture without progesterone (Biological)
Preterm postpartum blood samples without progesterone
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.
Intervention: Culture without progesterone (Biological)
Outcomes
Primary Outcomes
Maturation effects of progesterone on preterm and term placentas
Time Frame: One year
Differences observed in maturation of IMC cells into DC cells in term and preterm placentas
Inflammation characteristic effects of progesterone on preterm and term placentas
Time Frame: One year
Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone
Secondary Outcomes
No secondary outcomes reported