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NCT03211338 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
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