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

Primary Purpose

Obstetric Labor, Premature

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Culture with progesterone
Culture without progesterone
Culture with growth factors
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstetric Labor, Premature

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Preterm labor placentas and progesterone

Term labor placentas and progesterone

Preterm labor placentas without progesterone

Term labor placentas without progesterone

Term placentas from progesterone treated pregnancies

Preterm placentas from progesterone treated pregnancies

Term placentas not treated with progesterone in pregnancy

Preterm placentas not treated with progesterone in pregnancy

Term postpartum blood samples with progesterone

Preterm postpartum blood samples with progesterone

Term postpartum blood samples without progesterone

Preterm postpartum blood samples without progesterone

Arm 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
Maturation effects of progesterone on preterm and term placentas
Differences observed in maturation of IMC cells into DC cells in term and preterm placentas

Secondary Outcome Measures

Full Information

First Posted
July 5, 2017
Last Updated
June 22, 2022
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03211338
Brief Title
Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
Official Title
Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor, Premature

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preterm labor placentas and progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Term labor placentas and progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Preterm labor placentas without progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Term labor placentas without progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Term placentas from progesterone treated pregnancies
Arm Type
Active Comparator
Arm 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.
Arm Title
Preterm placentas from progesterone treated pregnancies
Arm Type
Active Comparator
Arm 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.
Arm Title
Term placentas not treated with progesterone in pregnancy
Arm Type
Active Comparator
Arm 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.
Arm Title
Preterm placentas not treated with progesterone in pregnancy
Arm Type
Active Comparator
Arm 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.
Arm Title
Term postpartum blood samples with progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Preterm postpartum blood samples with progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Term postpartum blood samples without progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Preterm postpartum blood samples without progesterone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Culture with progesterone
Intervention Description
Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Intervention Type
Biological
Intervention Name(s)
Culture without progesterone
Intervention Description
Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Intervention Type
Biological
Intervention Name(s)
Culture with growth factors
Intervention Description
Culture of placental IMC cells with growth hormones only and analysis
Primary Outcome Measure Information:
Title
Inflammation characteristic effects of progesterone on preterm and term placentas
Description
Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone
Time Frame
One year
Title
Maturation effects of progesterone on preterm and term placentas
Description
Differences observed in maturation of IMC cells into DC cells in term and preterm placentas
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinat Gabbay-Benziv, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
H̱adera
ZIP/Postal Code
38100
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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