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

NCT03211338 — Not applicable, Completed, 115 participants, Hillel Yaffe Medical Center

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Registry	NCT03211338
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	115 (Actual)
Sponsor	Hillel Yaffe Medical Center (Other gov)
Conditions	Obstetric Labor, Premature
Interventions	Culture with progesterone, Culture without progesterone, Culture with growth factors (Biological)
Dates	start 2017-07-15, primary completion 2022-06-06, completion 2022-06-06, first posted 2017-07-07, last updated 2022-06-23
Locations	1 site in Israel

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Preterm labor placentas and progesterone	Active comparator	Biological: Culture with 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.
Term labor placentas and progesterone	Active comparator	Biological: Culture with 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.
Preterm labor placentas without progesterone	Active comparator	Biological: Culture 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.
Term labor placentas without progesterone	Active comparator	Biological: Culture 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.
Term placentas from progesterone treated pregnancies	Active comparator	Biological: Culture with growth factors	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.
Preterm placentas from progesterone treated pregnancies	Active comparator	Biological: Culture with growth factors	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.
Term placentas not treated with progesterone in pregnancy	Active comparator	Biological: Culture with growth factors	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.
Preterm placentas not treated with progesterone in pregnancy	Active comparator	Biological: Culture with growth factors	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.
Term postpartum blood samples with progesterone	Active comparator	Biological: Culture 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.
Preterm postpartum blood samples with progesterone	Active comparator	Biological: Culture 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.
Term postpartum blood samples without progesterone	Active comparator	Biological: Culture 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.
Preterm postpartum blood samples without progesterone	Active comparator	Biological: Culture 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.

Culture with progesterone (Biological): Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Culture without progesterone (Biological): Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Culture with growth factors (Biological): Culture of placental IMC cells with growth hormones only and analysis

+Outcome measures

Primary outcomes

Inflammation characteristic effects of progesterone on preterm and term placentas [One year]: Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone
Maturation effects of progesterone on preterm and term placentas [One year]: Differences observed in maturation of IMC cells into DC cells in term and preterm placentas

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Hillel Yaffe Medical Center	Hadera	Israel

+Investigators

Rinat Gabbay-Benziv, MD, Principal investigator, Hillel Yaffe Medical Center