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

Obstetric Labor, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211338
• Other study ID #: HYMC-0061-17
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: June 6, 2022

Study information

• Verified date: June 2022
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obstetric Labor, Premature
• Premature Birth

Intervention

Biological:
• Culture with progesterone
Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
• Culture without progesterone
Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
• Culture with growth factors
Culture of placental IMC cells with growth hormones only and analysis

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	H_adera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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