Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
1 other identifier
interventional
115
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedStudy Start
First participant enrolled
July 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2022
CompletedJune 23, 2022
June 1, 2022
4.9 years
July 5, 2017
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (12)
Preterm labor placentas and progesterone
ACTIVE COMPARATORIMC 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.
Term labor placentas and progesterone
ACTIVE COMPARATORIMC 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 labor placentas without progesterone
ACTIVE COMPARATORIMC 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
ACTIVE COMPARATORIMC 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.
Term placentas from progesterone treated pregnancies
ACTIVE COMPARATORIMC 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.
Preterm placentas from progesterone treated pregnancies
ACTIVE COMPARATORIMC 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
ACTIVE COMPARATORIMC 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.
Preterm placentas not treated with progesterone in pregnancy
ACTIVE COMPARATORIMC 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.
Term postpartum blood samples with progesterone
ACTIVE COMPARATORCD-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.
Preterm postpartum blood samples with progesterone
ACTIVE COMPARATORCD-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.
Term postpartum blood samples without progesterone
ACTIVE COMPARATORCD-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.
Preterm postpartum blood samples without progesterone
ACTIVE COMPARATORCD-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.
Interventions
Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Culture of placental IMC cells with growth hormones only and analysis
Eligibility Criteria
You may qualify if:
- Placentas from term and preterm deliveries
- Singleton pregnancy
- Consent to participate
You may not qualify if:
- Pregnancies with obstetric complications
- Multiple gestation
- Maternal illness or fetal malformation known pre-delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rinat Gabbay-Benziv, MD
Hillel Yaffe Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 7, 2017
Study Start
July 15, 2017
Primary Completion
June 6, 2022
Study Completion
June 6, 2022
Last Updated
June 23, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share