NCT06884696

Brief Summary

The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 19, 2025

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

March 5, 2025

Last Update Submit

March 18, 2025

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

  • Placental inflammation

    Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.

    At delivery/birth

Study Arms (2)

Women with gestational diabetes mellitus

EXPERIMENTAL

Blood and placenta sampling will be obtained from cases= women with gestational diabetes mellitus

Other: Blood samples for inflammatory markersOther: Placental Extract

Healthy women with uncomplicated pregnancy

EXPERIMENTAL

Blood and placenta sampling will be obtained from controls= women with uncomplicated pregnancy

Other: Blood samples for inflammatory markersOther: Placental Extract

Interventions

Placental ExtractOTHER

Placental sampling after caesarean section

Healthy women with uncomplicated pregnancyWomen with gestational diabetes mellitus
Blood samples for inflammatory markersOTHER

Blood sampling

Healthy women with uncomplicated pregnancyWomen with gestational diabetes mellitus

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with gestational diabetes mellitus
  • Women with uncomplicated pregnancy
  • Age \>18 years
  • Singleton pregnancy

You may not qualify if:

  • Age \< 18 years
  • Infections (HIV,HCV)
  • Multiple pregnancy
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Specimen CollectionPlacental Extracts

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesTissue ExtractsComplex Mixtures

Study Officials

  • Chiara Tersigni

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 19, 2025

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2025

Last Updated

March 19, 2025

Record last verified: 2024-06

Locations

IT(1)