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

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 Overview

• Status: Completed
• Conditions: Obstetric Labor, Premature
• Intervention / Treatment: Biological: Culture with progesterone; Biological: Culture without progesterone; Biological: Culture with growth factors

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • H̱adera, Israel, 38100
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Biological: Culture with progesterone; Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Active Comparator: 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.	Biological: Culture with progesterone; Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Active Comparator: 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.	Biological: Culture without progesterone; Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Active Comparator: 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.	Biological: Culture without progesterone; Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Active Comparator: 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.	Biological: Culture with growth factors; Culture of placental IMC cells with growth hormones only and analysis
Active Comparator: 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.	Biological: Culture with growth factors; Culture of placental IMC cells with growth hormones only and analysis
Active Comparator: 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.	Biological: Culture with growth factors; Culture of placental IMC cells with growth hormones only and analysis
Active Comparator: 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.	Biological: Culture with growth factors; Culture of placental IMC cells with growth hormones only and analysis
Active Comparator: 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.	Biological: Culture with progesterone; Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Active Comparator: 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.	Biological: Culture with progesterone; Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Active Comparator: 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.	Biological: Culture without progesterone; Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Active Comparator: 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.	Biological: Culture without progesterone; Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One year
Maturation effects of progesterone on preterm and term placentas	Differences observed in maturation of IMC cells into DC cells in term and preterm placentas	One year

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Rinat Gabbay-Benziv, MD, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2017
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Inflammation; Premature Birth; Obstetric Labor, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Mitogens
• Other Study ID Numbers: HYMC-0061-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No