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

Not Applicable

Completed

• Conditions: Obstetric Labor, Premature
• Interventions: Biological: Culture without progesterone; Biological: Culture with progesterone; Biological: Culture with growth factors

• Registration Number: NCT03211338
• Lead Sponsor: Hillel Yaffe Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-07-15
• Status Verified: 2022-06
• Primary Completion: 2022-06-06
• Study Completion: 2022-06-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preterm labor placentas without progesterone	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	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.
Preterm postpartum blood samples with progesterone	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.
Preterm labor placentas and progesterone	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.
Preterm placentas from progesterone treated pregnancies	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	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.
Term placentas from progesterone treated pregnancies	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.
Term postpartum blood samples with progesterone	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.
Term postpartum blood samples without progesterone	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.
Term labor placentas and progesterone	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 placentas not treated with progesterone in pregnancy	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.
Preterm postpartum blood samples without progesterone	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 H̱adera, Israel