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

NCT ID: NCT03211338

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2022-06-06

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).

Detailed Description

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Conditions

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Obstetric Labor, Premature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Culture with progesterone

Intervention Type BIOLOGICAL

Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells

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.

Group Type ACTIVE_COMPARATOR

Culture with progesterone

Intervention Type BIOLOGICAL

Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells

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.

Group Type ACTIVE_COMPARATOR

Culture without progesterone

Intervention Type BIOLOGICAL

Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

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.

Group Type ACTIVE_COMPARATOR

Culture without progesterone

Intervention Type BIOLOGICAL

Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

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.

Group Type ACTIVE_COMPARATOR

Culture with growth factors

Intervention Type BIOLOGICAL

Culture of placental IMC cells with growth hormones only and analysis

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.

Group Type ACTIVE_COMPARATOR

Culture with growth factors

Intervention Type BIOLOGICAL

Culture of placental IMC cells with growth hormones only and analysis

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.

Group Type ACTIVE_COMPARATOR

Culture with growth factors

Intervention Type BIOLOGICAL

Culture of placental IMC cells with growth hormones only and analysis

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.

Group Type ACTIVE_COMPARATOR

Culture with growth factors

Intervention Type BIOLOGICAL

Culture of placental IMC cells with growth hormones only and analysis

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.

Group Type ACTIVE_COMPARATOR

Culture with progesterone

Intervention Type BIOLOGICAL

Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells

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.

Group Type ACTIVE_COMPARATOR

Culture with progesterone

Intervention Type BIOLOGICAL

Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells

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.

Group Type ACTIVE_COMPARATOR

Culture without progesterone

Intervention Type BIOLOGICAL

Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

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.

Group Type ACTIVE_COMPARATOR

Culture without progesterone

Intervention Type BIOLOGICAL

Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

Interventions

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Culture with progesterone

Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells

Intervention Type BIOLOGICAL

Culture without progesterone

Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

Intervention Type BIOLOGICAL

Culture with growth factors

Culture of placental IMC cells with growth hormones only and analysis

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rinat Gabbay-Benziv, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Other Identifiers

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HYMC-0061-17

Identifier Type: -

Identifier Source: org_study_id

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