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Completed

NCT Number: NCT03211338

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

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).

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Key information

Conditions

Obstetric Labor, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culture with progesterone

Biological

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

Culture without progesterone

Biological

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

Culture with growth factors

Biological

Culture of placental IMC cells with growth hormones only and analysis

Primary outcomes

  1. Inflammation characteristic effects of progesterone on preterm and term placentas

    Time frame: One year

    Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone

  2. Maturation effects of progesterone on preterm and term placentas

    Time frame: One year

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

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2017
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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