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

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified July 2017 by Hillel Yaffe Medical Center

Sponsor:

Information provided by (Responsible Party):

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT03211338

First received: July 5, 2017

Last updated: NA

Last verified: July 2017

History: No changes posted

Purpose

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).

Condition	Intervention
Obstetric Labor, Premature	Biological: Culture with progesterone Biological: Culture without progesterone


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Basic Science
Official Title:	Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone

Resource links provided by NLM:

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:

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
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


Estimated Enrollment:	400
Anticipated Study Start Date:	July 2017
Estimated Study Completion Date:	July 2018
Estimated Primary Completion Date:	July 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Preterm labor placentas and progesterone IMC cells taken from preterm labor placentas will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.	Biological: Culture with progesterone Progesterone, a steroid hormone will be cultured with placental IMC cells
Active Comparator: Term labor placentas and progesterone IMC cells taken from term labor placentas will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.	Biological: Culture with progesterone Progesterone, a steroid hormone will be cultured with placental IMC cells
Active Comparator: Preterm labor placentas without progesterone IMC cells taken from preterm labor placentas will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.	Biological: Culture without progesterone Culture of placental IMC cells without progesterone
Active Comparator: Term labor placentas without progesterone IMC cells taken from term labor placentas will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.	Biological: Culture without progesterone Culture of placental IMC cells without progesterone

Eligibility


Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211338

Contacts


Contact: Suzi Oberman-Farhy, MD	972-50-7728858	suziober@gmail.com

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators


Principal Investigator:	Rinat Gabbay-Benziv, MD	Hillel Yaffe Medical Center

More Information


Responsible Party:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT03211338 History of Changes
Other Study ID Numbers:	HYMC-0061-17
Study First Received:	July 5, 2017
Last Updated:	July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Inflammation Premature Birth Obstetric Labor, Premature Pathologic Processes Obstetric Labor Complications Pregnancy Complications	Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 11, 2017

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