CClinicalTrials.gg
CompletedNCT03211338Updated Jun 23, 2022

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

An interventional study of Culture with progesterone and Culture without progesterone in Obstetric Labor, Premature, sponsored by Hillel Yaffe Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-23.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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).

02

Conditions studied

03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 115 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Placentas from term and preterm deliveries
  • Singleton pregnancy
  • Consent to participate

Exclusion criteria

Exclusion Criteria:

  • Pregnancies with obstetric complications
  • Multiple gestation
  • Maternal illness or fetal malformation known pre-delivery
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • BiologicalCulture with progesterone

    Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells

  • BiologicalCulture without progesterone

    Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone

  • BiologicalCulture with growth factors

    Culture of placental IMC cells with growth hormones only and analysis

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: One year

  2. Maturation effects of progesterone on preterm and term placentas

    Differences observed in maturation of IMC cells into DC cells in term and preterm placentas

    Time frame: One year

07

Study locations

1 site
  • Hillel Yaffe Medical Center
    H̱adera, 38100, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03211338
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jul 7, 2017
Start date
Jul 15, 2017
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022
Last update
Jun 23, 2022

Study contacts

Rinat Gabbay-Benziv, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion