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

Hillel Yaffe Medical Center

Status: Completed

Conditions: Obstetric Labor, Premature

Treatments: Biological: Culture without progesterone; Biological: Culture with growth factors; Biological: Culture with progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03211338

HYMC-0061-17

Details and patient eligibility

About

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).

Enrollment: 115 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 12 patient groups

Preterm labor placentas and progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with progesterone

Term labor placentas and progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with progesterone

Preterm labor placentas without progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture without progesterone

Term labor placentas without progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture without progesterone

Term placentas from progesterone treated pregnancies

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with growth factors

Preterm placentas from progesterone treated pregnancies

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with growth factors

Term placentas not treated with progesterone in pregnancy

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with growth factors

Preterm placentas not treated with progesterone in pregnancy

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with growth factors

Term postpartum blood samples with progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with progesterone

Preterm postpartum blood samples with progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture with progesterone

Term postpartum blood samples without progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture without progesterone

Preterm postpartum blood samples without progesterone

Active Comparator group

Description:

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.

Treatment:

Biological: Culture without progesterone